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41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 20.0-70.0, Protein-energy; Imbalance Both sexes aged between 20-70 years Received stable hemodialysis at least 3 months Written informed consent Patients with malignant disease, acute infectious disease, inflammatory disease (such as collagen disease), advanced liver disease, and those taking any type of immunosuppressive medication are excluded | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-65.0, Acute Repetitive Seizures Breakthrough Seizures Male and female subjects between the ages of 6 and 65 years, inclusive. 2. Written informed consent to participate in the study. 3. Subject has a clinical diagnosis of Epilepsy and while on a stable regimen of anti-epileptic medication, still experiences bouts of seizures (e.g. frequent break through seizures or Acute Repetitive Seizures [ARS]), and who, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control at least 1 time a month on average. 4. Subject has a qualified caregiver or medical professional available that can administer study medication in the event of a seizure. 5. Subjects having either partial or generalized Epilepsy with motor seizures or seizures with clear alteration of awareness. 6. Female subjects of childbearing potential, defined as having a menstrual cycle and who are not surgically sterile or less than two (2) years postmenopausal, must complete a pregnancy screen and agree to utilize one of the following forms of contraception during the trial and for 21 days after the last dose of study drug: abstinence, hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (six months minimum). Subjects must have used the same method for at least one (1) month prior to starting the study. 7. No clinically significant abnormal findings in the medical history, on the physical examination or electrocardiogram (QTcF<450 msec for males and QTcF<470 msec for females). 8. Subjects and caregivers must agree to return to the study site for all study visits and must be willing to comply with all required study procedures A history of clinically significant gastrointestinal, renal, hepatic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject. 2. Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening. 3. Subjects with active major depression or a past suicide attempt, or any Suicidal Ideation of 3, 4, or 5 or any Suicidal Behavior in Lifetime using Columbia-Suicide Severity Rating Scale (C-SSRS). The pediatric C-SSRS should be used for subjects age 6 to 11. The adult C SSRS should be used for subjects 12 and greater years of age. 4. A history of allergic or adverse responses to diazepam or any comparable or similar product. 5. Participation in a clinical trial other than protocol DIAZ.001.04 within 30 days prior to Day 0. Participation in an observational (non-interventional) study is not excluded as long as there are no scheduling conflicts with this study. 6. Positive serum pregnancy test (ß-hCG) at screening for subjects age 12 or greater. 7. Positive blood screen for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse, except marijuana use for medical reasons. When marijuana was used for medical reasons in the opinion of the investigator, it is not considered as drug abuse and the patient can be enrolled even if the marijuana metabolites in the urine revealed as positive | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-9.0, Intellectual Disability Child aged under 9 Child has identified intellectual disability or genetic syndrome associated with intellectual disability (e.g. Fragile X Syndrome) Child uses only phrase speech (i.e. 2-3 word utterances) Child displays self injury, aggression, property destruction at home Family carers aged over 18 with capacity to consent Family carer speaks English as first language (to ensure that the child understands English and will therefore understand researcher) Child experiences health condition involving pain that is not well controlled by treatment Child is fully deaf / blind Child or family carer receiving active treatment in relation to child's behaviour (e.g. direct behavioural support, parenting programme etc.) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Age 18-65 2. Stable focal epilepsy, with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization. 3. Stable AED doses for at least 30 days 4. Epilepsy duration for > 2 years 5. Past/current treatment with > 4 AEDs. Vagal nerve stimulator treatment will be allowed and will not count as an AED. VNS setting must be stable for 3 months prior to enrollment. 6. Seizure frequency of ≥1/month Primary generalized epilepsy 2. Simple partial seizures without motor components or secondary generalization 3. Non-epileptic seizures 4. Progressive neurological disease including neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia 5. Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer 6. Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment 7. Psychosis within six months of enrollment. 8. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements; 9. Pregnancy 10. Use of any CNS-active investigational drugs within 3 months of enrollment. 11. Inability or unwillingness of subject or legal guardian/representative to give written informed consent | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Intellectual Disability ages above 18 years diagnosis of intellectual disability institution in Castelo Branco other co-morbilities associated not institutionalised | 2 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-99.0, Epilepsy Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization Male or female greater than 2 years of age Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm) Be able to tolerate wearing the device on the upper arm Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments Subject and/or Primary Caregiver must be competent to follow all study procedures Is able to read, speak and understand English At least 2 or more Emergency Department visits in the previous 12 months for seizure related care The subject is homeless or in a home without a power supply The subject is allergic to adhesives or any component of the electrode patch assembly The subject self-reports that she is pregnant or planning to become pregnant while using the device | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 22.0-999.0, Epilepsy Failure of adequate seizure control with prior use of at least 2 anti-seizure drugs. 2. at least one clearly identified and localizable likely seizure onset focus, as defined by the discharges (typically epileptiform spikes) and as identified by dEEG assessment through one or more routine clinical dEEG evaluations. This focus must be 2 to 3 cm from the head surface (to be reachable by TMS). Where multiple spike foci are present and meet these then the focus with either clinically relevant symptoms or the most spikes (or both) will be chosen as the target for treatment. 3. two or more partial seizures, with or without secondary generalization, in the last month, but less than 10 seizures per day. 4. Anti-seizure drug regimen has remained unchanged for the month before study entry, and there is reasonable likelihood of stability for the duration of the study, with the exception of allowing short-term rescue medications, such as lorazepam. 5. a history of epilepsy for at least 2 years. 6. age of 22 years and older If of childbearing potential, the patient must agree to use an effective method of birth control during the study and cease participation if pregnant. 2. Nursing mothers are excluded. 3. A history or condition of progressive brain disorders, serious systemic diseases, symptomatic cerebrovascular disease, cardiac disease, or alcohol abuse. Special conditions, for example, non-malignant brain tumors and vascular malformations, can be considered for entry on a case-by-case basis. Patients are not excluded on the basis of previous psychiatric hospitalizations or suicide attempts. 4. A history or condition of (generalized) status epilepticus or psychogenic seizures. 5. Presence of a cardiac pacemaker, vagus nerve stimulator, or metal implantation in the body (other than the teeth) including neurostimulators, cochlear implants, and implanted medication pumps. 6. Previous surgery involving opening the skull. 7. Unable to express presence of pain or discomfort | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Blepharospasm Patients with bilateral blepharospasm 2. Clinical symptoms more than 1 years. 3. Patients who are willing to undergo surgery. 4. Preoperative patients who had not been treated with botulinum toxin Patients with serious heart and lung dysfunction can not tolerate surgery. 2. The clinical symptoms of the patients less than 1 years. 3. Patients who received local botulinum toxin treatment for a long time. 4. Patients with severe mental disorders | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-85.0, Severe Sepsis Severe sepsis (according to American college of chest Physicians/ Society of Critical Care Medicine (ACCP/SCCM) criteria) Informed consent provided by patients or legally authorized representative Yin syndrome in syndrome differentiation (according to principles of traditional Chinese medicine (TCM) syndrome differentiation) Pregnant or nursing female Subject receiving immunosuppressive or immunoenhancement therapy in the past 3 months Patients with known or suspicious autoimmune diseases Patients not expected to survive 28 days due to end-stage disease or other uncorrectable medical condition Fasting subjects Known or suspicious allergy to any ingredient of Si-Ni-Tang Patients not expected to survive 5 days for various reasons | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Depression Epilepsy Age at least 18 years diagnosis of active epilepsy (that is, at least one epileptic seizure within the past 10 years or taking antiseizure medicines within the past five years) current depressive disorder (either major depressive disorder or dysthymic disorder, as determined by telephone interview with the MINI Neuropsychiatric Interview) no current antidepressant medication, or current antidepressant medication but no changes in dosage for at least one month prior to study (medication changes after study are permitted, given the pragmatic design of the trial) currently at least moderate self-reported depressive symptom severity, as operationalized by a score of at least 10 on the PHQ-9, a cut-off score that has been well validated ability to speak and read German access to the internet and personal possession of an appropriate device on which the internet-based intervention can be used regularly (e.g., smartphone, computer, laptop) expressed motivation to participate in the trial and use an internet-based intervention to acquire skills and knowledge that may aid in the amelioration of depression symptoms current psychotherapy other known major psychiatric disorder, such as bipolar disorder, schizophrenia or another psychotic disorder, or borderline personality disorder (based on the MINI interview) acute suicidality (that is, intention or plan to commit suicide, as assessed with the respective module of the MINI interview) newly prescribed antidepressant medication or change in antidepressant medication dosage in month prior to study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Bipolar Disorder BD patients Men or women, right-handed diagnosis of type 1 bipolar disorder, according to the DSM-IV aged from 18 to 65 years-old Native French speaker Affiliated to the social security Healthy Controls (HC) Men or women, right-handed aged from 18 to 65 years-old Native French speaker Affiliated to the social security BD patients recent alcohol and/or drug abuse or dependence significant general medical illness, including neurological disorders or head trauma sensorial impairment (visual and/or hearing) Contraindication to the use of MRI HC first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV recent alcohol and/or drug abuse or dependence significant general medical illness, including neurological disorders or head trauma sensorial impairment (visual and/or hearing) Contraindication to the use of MRI | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Epilepsy, Unspecified, Refractory (Medically) Seizure refractory to at least three standard antiepileptic medications at adequate doses, failed for lack of efficacy. This may a rescue medication designated use as PRN A minimum of 3 seizures per month for 2 months by patient diary started at intake interview Subjects should have focal seizures with or without secondary generalization Subjects should have evidence suggesting the focus within the periventricular white matter, basal ganglia, thalamus, hypothalamus, or mesial temporal lob has been previously determined as the source of seizures by standard clinical including at least the description of seizures, physical examination, neuroimaging, and video EEG monitoring capturing at least one seizure Subjects must be taking 2 medications during the Baseline period and the dosage must be stable A diagnosis of intractable lesional epilepsy which may Hypothalamic hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial tumor (DNET), Cortical dysplasia, Tuberous sclerosis, Focal cortical gliosis, or Predominately unilateral Mesial Temporal Lobe Epilepsy (MTLE) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.) Patients with malignant brain tumors Patients with a known history of psychogenic non-epileptic spells in the last three years Patients with a vagal nerve stimulator, deep brain stimulator, other implanted electronic device, or prior radiofrequency lesion techniques Lesions in the brainstem or cerebellum Subjects with symptomatic generalized epilepsy Subjects with only simple partial seizures Subjects who have had convulsive status epilepticus within 12 months prior to baseline Subjects with a prior diagnosis of psychogenic/non-epileptic seizures within the last 5 years | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Relevant are listed below Diagnosis of unilateral medial temporal lobe epilepsy (MTLE) confirmed clinically and with either (1) ictal scalp recording and MRI evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin Averages 1 or more complex partial seizures or secondary generalized seizures compatible with MTLE per month On stable antiepileptic medications Meets the for a medial temporal lobe resection and is a candidate for LITT years or older at the time of consent Relevant are listed below Previous diagnosis of psychogenic/non-epileptic seizures Previous diagnosis of primary generalized seizures IQ less than 70 Subject has a MRI-incompatible implanted electronic device or any metallic prosthesis or implant for which brain MRI is contraindicated | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Pain patients requiring endoscopic sinus surgery ASA score 1 or 2 patients with health care insurance approved consent any sinonasal malignant tumor renal failure, hepatic disorder, respiratory deficiency, cardiovascular diseases neurologic disorders alcohol or drugs addiction preoperative facial pain from an extranasal origin coagulation disorders antidepressive treatment | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-65.0, Autism Spectrum Disorder Intellectual Disability at Boston Children's Hospital (children) For ASD group: 1. Clinical diagnosis of a disorder on the autism spectrum. 2. Assessment using the Autism Diagnostic Observation Schedule. 3. Assessment using the Autism Diagnostic Interview-Revised. 4. Children ages 6-16. 5. IQ>70. 6. Verbal. at Beth Israel Deaconess Medical Center (adults) For ASD group: 1. Clinical diagnosis of a disorder on the autism spectrum. 2. Assessment using the Autism Diagnostic Observation Schedule. 3. Adults ages 21-65 Intracranial pathology, cerebral palsy, history of severe head injury, significant dysmorphology, or known intracranial lesion History of fainting spells of unknown or undetermined etiology History of head injury resulting in prolonged loss of consciousness History of seizures, diagnosis of epilepsy, or immediate family history of epilepsy Any progressive neurological disorder or signs of intracranial pressure Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure Metal implants or devices Substance abuse or dependence within the past six months Certain prescription medications that decrease cortical seizure threshold Pregnancy | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Temporal Lobe Epilepsy History of drug-resistant mesial temporal lobe epilepsy (MTLE) If the subject has a vagus nerve stimulator (VNS), must have failed to achieve sustained seizure freedom with the VNS implanted for at least 6 months On stable antiepileptic drugs (AEDs) (and/or stable VNS setting, if applicable) and compliant with medication use An average of at least 1 complex partial or secondarily generalized seizure compatible with MTLE per month Seizure symptoms and/or auras compatible with MTLE Video EEG shows evidence of seizures from one temporal lobe consistent with MTLE MRI has evidence consistent with mesial temporal lobe sclerosis Willing and able to remain on stable AEDs (and stable VNS setting, if applicable) for 12 months following the Visualase procedure Willing and able to comply with protocol requirements Able to complete study assessments in English or Spanish language Unwilling or unable to sign the study informed consent form Pregnant or intends to become pregnant during the course of the study Currently implanted with a device contraindicating MRI Progressive brain lesions and/or tumors not associated with epileptic disease state History of previous intracranial surgery for treatment of epileptic seizures Persistent extra-temporal or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes on EEG Seizures with contralateral or extra-temporal ictal onset on EEG Aura and/or ictal behavior suggest an extra-temporal focus MRI evidence of epileptogenic, extra-temporal lesions, dual pathology in the temporal lobe, or contralateral hippocampal MRI increased signal and/or loss of architecture If additional testing has been performed, results are discordant with the seizure focus scheduled for ablation | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-75.0, Hemiplegia Stroke Having had a first ischemic stroke within 6 months, or have already had a stroke in the same lesion zone No recurrence Responsible of a right or left hemiplegia Able to walk alone with or without technical assistance Over a distance of at least 10 meters Performance on the six-minute walk test less than 400 meters Without neurological history other than stroke Patients who did not have brain MRI after their stroke Patients with complete lesion of the primary motor cortex (as identified on MRI) Patients with an addiction to alcohol or drugs Patients with psychiatric disease, cognitive impairment disease, uncontrolled epilepsy, neoplastic disease, severe renal or pulmonary failure Patients with cerebellar syndrome associated Patients with clinical involvement of the brainstem (cranial nerve deficit) Patients who refused to sign the written consent Patients who have an ongoing pregnancy Patients under justice protection Patients with contraindication to practice aerobic training after stress test | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Severe Intellectual Disability Clinical diagnosis of syndromic or isolated severe intellectual disability (IQ <50) without a molecular diagnosis Recurrence in siblings (multiplex families) suggesting autosomal recessive inheritance (with or without parental consanguinity) or sporadic cases from a consanguineous union Conventional genetic tests performed (including array-CGH) and MRI/CT-scan available DNA samples from parents and from both unaffected or affected siblings available, for parental segregation and confirmation of candidate variations identified Availability of a signed informed consent To be affiliated or beneficiary of French social security/healthcare system Parents in the period of another study or as provided by the national register of volunteers High-probability diagnostic hypothesis for which a molecular test is available at lower cost than exome sequencing | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Arterial Embolization Subject is aged 18 years or over 2. Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment 3. Subject has provided written consent for the procedure. 4. Subject agrees to all follow up visits required by the protocol 5. The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization. 2. The subject has had acute cerebral bleeding within the last 6 months. 3. The patient is participating in another research study involving another investigational device, procedure or drug. 4. The brain AVM or DAVF or tumor has been previously treated with another embolization agent. 5. The subject has a bleeding disorder. 6. The subject is female and has a positive pregnancy test. 7. The subject has a life expectancy of less than 1 year. 8. Subject has a known allergy to contrast media used for radiography. 9. Subject has a known allergy to Dimethyl Sulfoxide DMSO (solvent for the embolic product). 10. Subject has a condition that would prevent them attending follow up visits for up to 1 year. - | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 9.0-999.0, Refractory Epilepsy years old or older An established diagnosis of medically-refractory neocortical epilepsy (as determined by the referring clinician), with a clearly defined seizure focus Diagnosis of epilepsy with focal seizures with or without secondary generalization (International League Against Epilepsy classification). Diagnosis established by clinical history and an electroencephalogram consistent with localization-related epilepsy Continued seizures despite adequate dosage in trials of at least 2 or more antiepileptic medications within approximately the last 3 years At least one clearly identified and localizable epileptogenic zone from which 80% or more seizures arise, as defined by the referring clinician Currently on 1-4 anti-epileptic drugs (AEDs) with no changes in antiepileptic drug doses in the 3 weeks prior to enrollment in the study and no planned dose changes during the trial and through the primary endpoint A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and generation of electrical fields A reported average of at least 3 seizures per month (focal or secondarily generalized) over the three months prior to enrollment, and a minimum of 4 seizures recorded during the 8-week baseline period, with no 21-day seizure-free period during the 8 week baseline Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. All female participants of child bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control including: oral hormonal contraceptives; implanted hormonal contraceptives, diaphragm with spermicide; condoms; intra-uterine device; abstinence Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data Uncertainty regarding the diagnosis of medically-refractory epilepsy History of Non-epileptic or psychogenic seizures, Primary generalized seizures, Status epilepticus in the last 12 months, Suspicion for or a significant history of syncope, Coexisting significant medical condition that is not in good control, Progressive neurologic disease, Progressive brain disorders, Serious systemic diseases, Symptomatic cerebrovascular disease, Cardiac disease, Chronic skin disease or Damaged skin on scalp that would interfere with tDCS stimulation Any cranial metal implants (excluding dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator) Previous surgeries opening the skull Active or recent substance abuse or dependence within the past year No medication is an absolute from tDCS/TMS. Medications will be reviewed and a decision about will be made based on the following: patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system (CNS) active drugs. The published TMS guidelines review of medications to be considered with TMS will be taken into consideration Any condition that makes the subject, in the opinion of the investigator, unsuitable for the study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-65.0, Epilepsy Drug-resistant partial epilepsy justifying a SEEG exploration Intellectual capacities compatible with the award of cognitive tasks Pregnant or lactating women Patient deprived of liberty by a judicial or administrative Major patient subject to a measure of legal protection | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-86.0, Refractory Epilepsy Patients with refractory focal epilepsy Initiation of perampanel between 05/2014 and 04/2015 Exact date of initiation of Perampanel not defined Patients without follow-up data | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Male or female 18-65 years Presenting focal epilepsy on the following arguments Crisis with clinical symptoms indicating focal seizure & / Or crisis or critical focal inter-recorded on EEG interpreted by a neurologist with expertise in the field of epilepsy Having not yet received a CSF analysis From unknown cause No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG No argument for metabolic or neurodegenerative genetic epilepsy Normal neurological examination structural abnormality found in brain MRI (except temporal hyperintensity and / or sclerosis of the hippocampus) Background Neurological: hyperthermic seizures in childhood, neonatal distress, history of seizures related to a circumstance, inflammation or infection of the CNS Taking toxic: chronic alcoholism, narcotic consumption The case for a genetic / metabolic neurodeg ear /: generalized EEG / photosensitivity / family history of epilepsy / autism / disorder syndrome psychomotor development / dysmorphic syndrome / extrapyramidal syndrome associated discharge History of thyroiditis or m. system (LEAD, SGS, PR, Sarcoidosis) Immunosuppression innate or acquired IC lumbar puncture or have already received a lumbar puncture before in the protocol Person under supervision or guardianship | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 3.0-70.0, Epilepsy epilepsy diagnosed by typical electroencephalogram (EEG) and Magnetic resonance imaging (MRI) frequent relapses of epilepsy (> one seizure per 6 months) at a stabilize extent every year complicated with certain brain disease, including tumor,injury,cerebrovascular disease complicated with other severe disease, including cancers, organ failure, heart diseases Follow-up less than 6 months | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-100.0, Metabolic Disease Propionic Acidemia Organic Acidemia Participants of any gender or ethnicity over 1 month of age are eligible to enroll remotely for collection of outside records and natural history data Participants of any gender or ethnicity over 2 years of age are eligible to enroll in the full study for remote or on-site evaluation Participants with biochemical, molecular or enzymatic evidence of propionic acidemia Participants with suspected genetic but unknown types of propionic acidemia may also be invited to participate Pregnant patients are eligible to participate in the study. However, they may not take part in some procedures such as tissue collection, stable isotope, GFR testing, and brain or cardiac MRI until the pregnancy is concluded The principal investigator may decline to enroll a patient for reasons such as being medically unstable, residing in a hospital, on dialysis, sub-optimal metabolic control, being treat for an infection, or for any concerns arising after reviewing the patient s medical records | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Subject is 18 to 65 years old. 2. Subject does not have coagulopathy, ventricular anatomic distortion or abnormally low brain weight or significant volume loss etc. and is approved to have surgery. 3. Subject had onset of epilepsy after age 5, had normal brain development up to age 5, and has full scale IQ > 70 by testing or functional assessment. 4. Subject has brain volume which is not noted to be abnormally small due to atrophy by either the radiologist reading on MRI scan or the treating clinicians (the neurosurgeon) review of the MRI scan. 5. Subject has had confirmed epilepsy for a minimum of 1 year, with diagnosis of focal seizures with temporal lobe onset, with or without secondarily generalized seizures, as defined by the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981). 6. In the opinion of the investigator, subject has disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility. 7. Subject has had a CT or MRI of the brain to rule out progressive structural lesions. 8. Subject has had an EEG or video EEG or invasive monitoring within the past 3 yrs consistent with partial seizures (a normal interictal EEG is consistent with partial seizures) 9. Subject has previously failed at least 3 AEDs in single or combination use. 10. Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium) and has been on a stable dosing regimen for 1 month prior to Screening. 11. Subject has completed all investigations necessary to satisfy the PI that noninvasive therapies are not likely to be satisfactorily successful. 12. For the 3 months before informed consent an average of four or more clinically significant focal seizures of temporal lobe onset, with or without secondary generalization, per month. Only seizures with objectively visible manifestations should be counted. The subject should have no period longer than 30 days in the 3 months prior to enrollment with less than 2 seizures. Seizures of hippocampal origin are preferred if the seizure origin is known or determined from imaging and seizure localization. 13. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver. 14. Subject has hearing, vision, and physical abilities adequate to perform assessments, with or without corrective aids, including keeping a seizure and medication diary during study follow-up. 15. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements. 16. Medically refractory for more than one year. 17. Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing. 18. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual. 19. Women of childbearing potential must be using a medically accepted method of contraception and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine or blood sample collected at Screening. Non-childbearing potential is defined as any female who is post menopausal since the last 1 year or has had hysterectomy or bilateral oophorectomy or is surgically sterilized. Medically accepted forms of birth control 1. Intrauterine device in place for at least 3 months 2. Adequate barrier methods (e.g., diaphragm and foam), or an oral contraceptive in combination with another method (e.g., spermicidal cream). An oral contraceptive alone is not considered adequate for this study. If on hepatic inducing AEDs which could lower serum hormone levels (phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, zonisamide, rufinamide, lacosamide) then an oral contraceptive must have minimum dosage equivalent to 50 µg daily of ethinyl estradiol Subject has any significant neurologic disease other than epilepsy. 2. Subject has history, within 12 months prior to Screening, of repetitive seizures that cannot be counted. 3. Subject has pseudoseizures or seizures secondary to illicit drug or alcohol use, neoplasia, active CNS infection, demyelinating disease, degenerative neurological disease, progressive central nervous system disease or metabolic illness. 4. Subject has been diagnosed with partial motor, primarily generalized seizures or has been diagnosed with psychogenic or nonepileptic seizures in the preceding year. 5. Subject has had status epilepticus refractory to benzodiazepines and phenytoin within one year prior to Screening 6. Subject is currently taking neuroleptic medication for behavior control. 7. Subject is taking scheduled doses of benzodiazepines or has required, in the 3 months prior to Screening, benzodiazepine use more than 4 times per month for seizure control. One use is defined as taking up to 3 doses in a 24 hour period. 8. Subject is currently implanted with an activated DBS, or RNS device used for treatment of a neurologic or psychiatric condition. 9. Subject has VNS and the VNS stimulation parameters are not stable. Stable shall be defined such that the stimulation parameters have been changed in the last 4 months or the patient/designee is able to report "magnet swipe" during the same time period. 10. Subject is currently taking oral valproic acid or sodium divalproex. 11. Subject has refractory motor seizures. 12. Subject has had more than 10 seizures in one day or more than 300 seizures in one month within the last year. 13. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon. 14. Subject has unstable depression being treated with more than 1 anti-depressant medication, or has current evidence of or history within the past 2 years of DSM-IV for any major psychiatric disorder including psychosis, major depression, bipolar disorder, and prior suicide attempt within five years. Also excluded are subjects with a history of postictal psychosis or psychosis or depression secondary to a discontinued AED. 15. Subject has had alcohol or substance abuse within the past 5 years. 16. Subject has uncontrolled Type I or Type II diabetes, hypercoagulability. Controlled diabetics for >12 months as evidenced by HbA1C <8% can be included in study based on Investigators assessment. 17. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%. 18. Subject has liver function tests aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at Screening ≥ 3 times the upper limit of normal, or clinically significant renal disease or insufficiency. 19. Subject has elevated (clinically significant thrombocytosis) or decreased (< 175/μL) platelet count. Subjects should not be taking aspirin or nonsteroidal anti-inflammatory drugs within the week before and week after implantation of catheter and pump. 20. Subject has abnormal prothrombin time or INR (> 14 seconds) or partial thromboplastin time (> 50 seconds). 21. Subject has, after 3 minutes in the supine position, systolic blood pressure < 90 or > 180 or pulse outside the range of 50-100 beats per minute. 22. Subject has had cancer within 3 years prior to Screening with the exception of squamous and basal cell carcinomas of the skin, and in situ carcinoma of the breast or cervix. 23. Subject is on chronic anticoagulants or, in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason. 24. Subject has known HIV infection or known or suspected prion disease. 25. Subject has known allergies to drugs or excipients. 26. Subject is breastfeeding. 27. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Electroencephalography Male or female subjects aged 18-65 years Provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the IRB guidelines Subjects in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations including demonstration of normal renal function Patient with focal-onset seizures with or without secondary generalized seizure History of epilepsy for at least 2 years The subject must have had an EEG or clinical seizure consistent with partial epilepsy A history of non-epileptic or psychogenic seizures Women who are pregnant or lactating Any clinically significant laboratory abnormality which, in the opinion of the investigator, will the subject from the study Liver transammases (AST and ALT) cannot exceed twice the upper limit of normal and total and direct bilirubin must be within normal limits An active CNS infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the subject's ability to participate in the study Suffering from psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; subject with current major depressive episode (or within 6 months) A history of alcoholism, drug abuse, or drug addiction within the past 2 years History of regular alcohol consumption exceeding 2-3 units/day for females and 3-4 units/day for males History of regular use of tobacco or nicotine-containing products exceeding the equivalent of 5 cigarettes per day | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy adults aged 18 years or older diagnosis of epilepsy who are being considered for treatment with Clobazam known untreated moderate or severe sleep apnea major circadian rhythm disorders | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy, Temporal Lobe are as follows 1. Age ≥ 18 2. The patient must suffer from drug resistant mesial temporal lobe epilepsy as determined by a consensus of providers at weekly epilepsy surgery conferences held by the Duke Epilepsy Center 3. The patient must be a candidate for LITT for MTLE as determined by a consensus of providers at weekly epilepsy surgery conferences held by the Duke Epilepsy Center are as follows 1. Age ≤ 18 2. Lack of consensus on localization of MTLE 3. Multifocal epilepsy 4. History of prior epilepsy surgery 5. Lack of consensus on candidacy for LITT 6. Pregnancy 7. Patient without capacity to provide legal consent | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 15.0-65.0, Epilepsy Bereaved family: Parents or spouse/husband who contact the coordination unit of the RSME in order to notify an epilepsy related death and who consent for an interview regardless of the cause of death and timeframe between death and interview Patients with epilepsy: Patients having a secure diagnostic of epilepsy with active epilepsy (treated or not) or in remission under treatment or without treatment aged from 15 years to 65 years old Relatives of patients with epilepsy: Parents or spouse/husband invited by a patient with epilepsy to participate to the interview who consent to participate Patients or relatives with learning difficulties Refusal of participation of the patients or relatives or legal representatives for patients aged under 18 years old Refusal for audio recording | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-12.0, Absence Epilepsy Epilepsy, Absence Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. 2. An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58). 3. Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years. 4. Aged 6-12 years 5. Permitted accompanying factors A few generalized tonic-clonic seizures (assessed individually according to International League Against Epilepsy [ILAE] statements Mild myoclonic eye(lid) movements Co-morbidities: Attention deficiency/concentration disorders, autism, dyslexia and anxiety. These do not form as this is frequently seen in children with absence seizures and it might be uncertain if the co-morbidity is a manifestation of the absence epilepsy A potential subject (both for the control and patient group) who meets any of the following will be excluded from participation in this study A diagnosis according to ILAE of the following epilepsy syndromes: Juvenile Absence Epilepsy; Eyelid myoclonia with absences; Dravet syndrome; Epilepsy with myoclonic-atonic seizures; Epilepsy with Myoclonic Absences; Lennox-Gastaut syndrome; Frontal Lobe Epilepsy or other focal epilepsy A confirmed diagnosis of epilepsy/seizures for more than 2 years (59) Recent hospitalizations in the last months or a history which might limit participation in or completion of the study protocol Behavioural characteristics which might hamper the gathering of useful MRI data Intellectual disability or other diseases/causes that may underlie cognitive impairment (i.e. neurodegenerative diseases) History of major head trauma or head/brain surgery MRI lesions on (previous) structural brain MRI or CT-scans or symptomatic epilepsies (e.g. epilepsy related to tumours, vascular abnormalities, congenital dysgenesia) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Diagnosis of epilepsy Negative health event within the last 6 months Able to provide written consent and participate in study procedures Immediate risk of self-harm Dementia Pregnancy Unable to read/understand English | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-99.0, Convulsion, Non-Epileptic A subject will be eligible for in this study if the following apply Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission Male or female between the ages of 2-99 Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments have been established for this study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Generalized Convulsive Status Epilepticus All consecutive GCSE patients (after the failure of first-line diazepam treatment) who were admitted in the emergency room or neurocritical care unit in Xuanwu Hospital of Capital Medical University Unstable vital signs, such as a systolic blood pressure of <90 mm Hg, a pulse of <60 beats per min, or an arterial blood oxygen saturation of <90% Liver dysfunction (alanine transaminase or total bilirubin of more than twice the normal upper limit) Neurologic emergency requiring immediate surgical intervention Pregnancy or breast feeding Hypersensitivity to study drugs | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Severe Sepsis Common for ICU patients : Signed informed consent, Patient affiliated or entitled to a social security, aged over 18 years for blood donor voluntary : to weigh more than 50 kg for severe sepsis group : Sepsis with failure of at least one organ, severe sepsis for less than 72 hours, sepsis with bacteria S. aureus, S. pneumoniae or E. coli for uninfectious inflammatory syndrome group : patients operate since less than 24 hours of hip or knee surgery, Absence of systemic infection failure to participate at the study Patients with a aspirin treatment has continued throughout severe sepsis Patients with an appropriate antibiotic therapy for more than 72 hours Patients with a platelet transfusion in the week before or 72 hours after a surgical gesture or the occurrence of sepsis Patients with the platelet account is less than 30 000 per cubic millimeter the day of the sampling Patients with a severe sepsis who had a surgical gesture previous week the All clinical sequelae or biological at the selection pregnant woman Patients with a treatment by platelet aggregation has continued throughout severe sepsis | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Epilepsy Age >18 Known diagnosis of Epilepsy Expected to experience seizures during the period of the study as determined by the PI Able to meet with the Sponsor representative at home Trauma/broken skin on forehead Patient can not follow or comply with instructions Patients who are unable to independently provide an informed consent Patients with major psychiatric co-morbidities Patients with psychogenic non-epileptic seizures | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 21.0-99.0, Severe Sepsis All adult patients (>18 years old) admitted to ICU plus Severe sepsis defined as 2 or more or the following Temperature >38oC or < 36oC Heart rate > 90 beats per min Respiratory rate >20 breaths per min or PaCO2 <32 mmHg White cell count > 12,000/microL or < 4,000/microL PLUS presence or presumed presence of infection PLUS evidence of organ dysfunction as defined by either of the following Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) < 65 mm Hg; or on vasopressors Hyperlactatemia: Serum lactate >/= 2 mmol/L (18 mg/dL) >48hr from admission to ICU Patients who are not expected to survive >48hrs by the managing team Refusal to consent to study Allergic to glutamine or its constituents Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition Patients with a primary admission diagnosis of burns (>30% body surface area) Patients whose weight <40kg or >200kg Previous randomization to this study Enrolled in a related ICU interventional nutrition study Pregnant patients or lactating mothers with the intent to breastfeed | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Any patient with epilepsy with either active seizures or interictal EEG changes (for scalp electrodes group) Any patient with epilepsy with either active seizures under evaluation for epilepsy surgery (for intracranial electrodes group) Ability to give informed consent none | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Seizures Traumatic Brain Injury Patients who have suffered intracranial injury identified by CT Scan Age less than 18 Pregnant patients Death in ED Seizure history or use of antiepileptic medication prior to admission Contraindication to study drug Any post-injury seizures prior to randomization | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-18.0, Epilepsies, Partial Study subjects will pediatric patients from birth to 18 years of age with a known seizure disorder who are being admitted to the epilepsy monitoring unit (EMU) or the ICU for further workup or medication management of their epilepsy. Subject will be eligible for the study if: 1. they have a diagnosis of partial (focal) epilepsy 2. standard of care long term EEG monitoring is planned 3. during the past 3 days to 1 week prior to EMU admission, have had an average of at least one seizure per day at time of admission to EMU history of unrepaired or palliated congenital cyanotic heart disease 2. history of traumatic head injury to the extent that precludes safe and consistent placement of NIRS-EEG probes. 3. diagnosis of Primary generalized epilepsy 4. Allergy or sensitivity to tape or adhesives 5. Guardian or patient do not give consent/assent to participate in the study 6. Clinical care provider or investigator determines the patient is not appropriate candidate for the study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Moderate-to-severe Atopic Dermatitis AD according to the United Kingdom (UK) working party diagnostic Moderate to severe AD Objective > 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Partial Seizures (With or Without Secondary Generalized Seizures) Primary Generalized Tonic-clonic Seizures Epilepsy participants at least 18 years of age with Partial seizures (with or without secondary generalized seizures) Primary generalized Tonic-clonic seizures Participants previously treated with Fycompa | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-17.0, Partial Seizures (With or Without Secondary Generalized Seizures) Primary Generalized Tonic-clonic Seizures Epilepsy participants from 12 to 17 years of age with Partial seizures (with or without secondary generalized seizures) Primary generalized Tonic-clonic seizures Participants previously treated with Fycompa | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Cases : Any patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years who died as a result of confirmed or probable SUDEP or NEAR SUDEP during the study period. Controls : Patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years and matched by: age, epileptic syndrom and level of seizure controls For cases and controls :patient not living in France, refusal of participation | 2 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Epilepsy Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis Subjects that experience surgical complications during the implant procedure will be excluded from the study | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Epilepsy Depressions, Refractory Age 18 or older Able and willing to provide informed consent Diagnosis of epilepsy confirmed by the study neurologist (KB) English-speaking Not pregnant Able to safely undergo MRI (as assessed by MRI safety form) Have a family member or friend (proxy) who will be able to bring the patient to the hospital and serve as a safety monitor during stay in study hotel for two consecutive nights Patients on stable doses of current antiepileptic and antidepressant medications for 1 month Significant cognitive impairment measured by the Montreal Cognitive Assessment (MOCA) <23 History of other major psychiatric disorders (e.g., schizophrenia, bipolar disorder, substance use disorder (except caffeine and nicotine) or presence of unstable medical comorbidities Actively/imminently suicidal (QIDS item 12 score > 2 or Mini-International Neuropsychiatric Interview (MINI) Suicidality module score > 16) Greater than 10 seizures per week during 1 month prior History of stroke, moderate-severe traumatic brain injury or other major neurological disorder Any magnetic or implanted device that will interfere with ability to safely receive MRI and/or TMS treatment | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Severe Sepsis Adult patients with severe sepsis or septic shock diagnosed less than 24 hours (defined as D0) and hospitalized in the medical resuscitation department of the Amiens-Picardie University Hospital The definitions of severe sepsis and septic shock are the result of the consensus of the Société de Réanimation de Langue Française dating from 2005 Sepsis refers to a systemic inflammatory response syndrome (SIRS) in the presence of suspected or identified infection. Sepsis is said to be severe when lactate> 4 mmol / L or arterial hypotension prior to filling or organ dysfunction is present (one is sufficient): hypoxemia with a PaO2 / FIO2 <300 ratio, renal failure with Hepatic insufficiency with INR> 4 or bilirubin> 78 μmol / l, thrombocytopenia (platelets <100 000 / mm3) and hepatic insufficiency> 176 μmol / l, coagulation disorders with INR> 1.5 Disorders of higher functions with a Glasgow Coma Score <13 Finally, septic shock is defined as a severe sepsis condition with persistent hypotension despite a well-conducted vascular filling (20-40 ml / kg isotonic saline) Patient with active neoplasia, immune deficiency, autoimmune disease or autoimmune disease Patient under tutorship or curatorship Taking an immunomodulatory or immunosuppressive treatment at the time of the study or the year prior to hospitalization for sepsis Antecedent or haematopoietic graft in progress Pregnancy in progress Known history of infection with human immunodeficiency virus (HIV) type 1 or 2 or with hepatitis B or C virus Patient with agranulocytosis (defined as neutrophils <0.5 G / L) | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 40.0-999.0, Stroke The for the participants included in this study involved both male and female of 40 year old or more of different body weights, and able to speak Arabic. Participants with at least one risk factor like hypertensive, diabetic, and dyslipidemia will be included in this study A family member of any participants will be excluded and will not participate in this study | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-80.0, Epilepsy Experience ≥ 3 seizures/month in the month prior to starting study (any type of seizure will count) No status epilepticus in the last 12 months No change in medication in last 30 days Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant) Presence of intracranial metal (e.g., aneurysm clip) Unable to cooperate with non-sedated, navigated TMS testing | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 25.0-75.0, Post-stroke Depression First-time ischemic stroke with clinical and MRI or CT findings of basal ganglia ischemic stroke and a diagnosis of depression due to stroke based on The Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and The International Classification of Diseases-10 (ICD-10-CM code 293.83[F06.32]); 2. Aged 25-75 years with a recent (from 3 weeks to 3 months) ischemic stroke; 3. Clear signs of neurological deficits in the acute phase; 4. Clear consciousness; 5. Right-handedness Aphasia or severe cognitive impairment, severe hearing impairment, or severe language comprehension deficits due to other causes; 2. Other cerebral diseases such as Parkinson's disease, encephalitis, dementia, multiple sclerosis, head injury, ect.; 3. Severe systemic disease or ongoing neoplasia; 4. Ongoing post-operative recovery; 5. Prior history of depressive disorders or major trauma within 1 year, severe depression or any other severe mental disorders; 6. Current or prior antidepressant use for any reason; 7. Addiction to drugs, alcohol or other substances; 8. Contraindications of MRI scan and rTMS treatment such as pacemaker implantation, a history of epilepsy, major head trauma, and seizures, ect; 9. Pregnant or breast-feeding women; 10. Participation in other clinical research projects; 11. Refusal to sign informed consent of this study | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epileptic Seizure Creatine Kinase Lactate Epileptic Generalized Tonic-clonic Seizure Any generalized convulsive seizure defined by a transient loss of consciousness with the occurrence of tonic-clonic movements Beginning less than 4 hours In a highly evocative context of the crisis by the presence of: witnesses and/or Urine loss, Tongue bite and/or personal medical history of epilepsy and/or Favorable context: sleeping debt, drug withdrawal, lights stimulations, video games and/or Impression of "already lived", already experienced before the discomfort and/or Break contact, and/or Unusual posture with hypertonia and/or Amnesia of the episode and/or Post-episode Confusion Inaugural or recurrent Patient Refusal <18 years Pregnancy Sepsis, fever> 38 ° Shock State Myocardial infarction Unbalanced Diabetes Hepatocellular insufficiency Drug and Toxic Use Taking Metformin | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Developmental and/or Epileptic Encephalopathies Has a documented clinical diagnosis of developmental and/or epileptic encephalopathies with countable bilateral motor seizures, defined as an average of greater than or equal to (>=) 2 per month during the past 3 months, based on the investigator's assessment, and a monthly average of >=1 per month during the Baseline Period, based on the seizure diary record. 2. Has been taking 1 to 4 antiepileptic drug (AEDs) at a stable dose for >=4 weeks before Screening and the participant or participant's legally acceptable representative is willing to keep the regimen(s) stable throughout the study. 3. Has an average of >=1 bilateral motor seizure per month during the 4-week Baseline Period (that is., drop seizures, tonic-clonic, tonic, bilateral clonic, atonic, myoclonic-atonic, myoclonic-tonic-clonic, focal seizures with bilateral hyperkinetic motor features). 4. Must agree to not post any participant's personal medical data related to the study or information related to the study on any web site or social media site (example, Facebook, Twitter) until the study has been completed. 5. For participants with G-tube/PEG tube, G-tubes/PEG tubes should have been placed and been functioning for at least 3 months prior to screening. Naso-gastric tubes are not allowed Has received TAK-935 in a previous clinical study or as a therapeutic agent. 2. Was admitted to a medical facility for treatment of status epilepticus requiring mechanical respiration within 3 months before Screening. 3. Had a vagal nerve stimulator implanted within 6 months before Screening and settings have been changed within 1 month of the Screening Visit and/or anticipated to change during the study. 4. Is on ketogenic diet that has been started within 6 months of the Screening Visit, has been changed within 1 month of the Screening Visit, or is anticipated to change during the study. 5. Has degenerative eye disease. 6. Has a history of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening. If the participant is unable to comply with the C-SSRS due to developmental status, a parent proxy may be used for the completion of the C-SSRS. The Investigator may also use clinical judgment, which must then be documented in the source document. 7. Positive for human immunodeficiency virus, hepatitis B, or hepatitis C infections. (Note that participants who have been vaccinated against hepatitis B [hepatitis B surface antibody (Ab)-positive] who are negative for other markers of prior hepatitis B infection [example, negative for hepatitis B core Ab] are eligible. Also note that participants who are positive for hepatitis C Ab are eligible as long as they have a negative hepatitis C viral load by quantitative polymerase chain reaction [qPCR]). 8. Has an abnormal and clinically significant ECG at Screening in the opinion of the investigator, for example, second or third degree heart block or a corrected QT interval (QTc) greater than (>) 450 millisecond (msec). Entry of any participant with an abnormal but not clinically significant ECG must be approved and documented by signature by the principal investigator or appropriately qualified delegate. 9. Has abnormal clinical laboratory test results at Screening that suggest a clinically significant underlying disease. If the participant has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5*the upper limit of normal (ULN), the Medical Monitor should be consulted. 10. Has received any excluded medications, procedures, or treatments during the time periods. 11. Has any a history of alcohol, opioid, or other drug use disorder, as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within the previous 2 years before Screening. Medical marijuana use is allowed. 12. Has unstable, clinically significant neurologic (other than the disease being studied), psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 9.0-99.0, Acne Vulgaris Male or female at least 9 years of age and older; 2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit; 4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; 5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; 6. Subjects with two or fewer nodules Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema; 3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. Subjects with a facial beard or mustache that could interfere with the study assessments; 5. Subjects with more than two (2) facial nodules; 6. Evidence or history of cosmetic-related acne | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-99.0, Non-Epileptic Seizure Motor Seizure Epilepsy Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or female between the ages of 18-99. 4. If female and of childbearing potential, has a negative pregnancy test. 5. Can understand and sign written informed consent prior to the performance of any study assessments. 6. Subject must be competent to follow all study procedures Intracranial EEG electrodes are being used | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Epilepsy Potential subjects meeting all of the following may be included in the study: 1. Subjects scheduled for admission to the institution's EMU, GCRC (General Clinical Research Center) or similar facility for evaluation within 28 days. 2. Male and female subjects between 18 to 65 years of age, inclusive. 3. Subjects having a body weight of ≥ 40 kg to 111 kg. 4. Subjects have a clinical diagnosis of epilepsy and are scheduled to be admitted to an Epilepsy Monitoring Unit (EMU) for extracranial video-Electroencephalogram (EEG) recording of a seizure event for evaluation of their epilepsy. 5. Subjects have an average frequency of > 1 seizure every 3 days or > 10 seizures / month as documented by seizure diaries dispensed at the Screening Visit and verified prior to initiation of Period A or Period B. 6. Female subjects have a negative serum pregnancy test at Screening. Female subjects of childbearing potential (i.e., not surgically sterile or 2 years postmenopausal) must have a negative pregnancy test at screening and a partner who is sterile, agree to abstinence, be practicing double barrier contraception or using an FDA approved contraceptive (e.g., licensed hormonal or barrier methods) for greater than 2 months prior to screening visit and commit to an acceptable form of birth control for the duration of the study and for 30 days after participation in the study. 7. Subjects are currently receiving at least one antiepileptic medication. 8. Subjects or subject's legally authorized representative (LAR) must be willing and able to complete informed consent/assent and HIPAA authorization. 9. Subjects must agree and must be willing to comply with all required study procedures while in the EMU or GCRC. 10. Ability to comprehend and be informed of the nature of the study, as assessed by the PI or Sub-Investigator. 11. Ability to consume standard meals. 12. Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements Potential subjects meeting any of the following will be excluded: 1. Subjects having a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months. 2. Subjects having respiratory failure (or is at risk for respiratory failure) or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen. 3. Female subjects who are lactating or positive serum pregnancy test (ß-hCG) at screening for female subjects ≥12 years of age. 4. Subjects with severe psychiatric disease that in the Investigator's judgment would prevent the patient's successful completion of the study. 5. Subjects who have an episode of status epilepticus, as determined by the Principal Investigator/Sub-Investigator, at any time during Period B (EMU, GCRC or similar facility Visit 6. Subjects with known history or presence of any clinically significant hepatic (e.g. hepatic impairment), renal/genitourinary (renal impairment, kidney stones), psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator and confirmed by Sponsor via written communication prior to subject enrollment. 7. Subjects with any clinically significant illness other than epilepsy within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator. 8. Subjects with any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator. 9. Subjects with any significant lesion of the oral cavity or having oral prophylactic procedures within 30 days prior to first dosing. 10. Subjects with a QTc interval QTcF>450 msec for males and QTcF>470 msec for females on screening ECG, unless determined as not clinically significant by the Investigator. 11. Subjects with a positive test result for any of the following: drugs of abuse (amphetamines, cocaine, opiates, or phencyclidine), a positive breath alcohol test. 12. Subjects with a known history or presence of: a. Alcohol abuse or dependence within one year prior to first drug administration; b. Drug abuse or dependence; c. Hypersensitivity or idiosyncratic reaction to diazepam, its excipients, sodium phosphates; and/or related substances, e.g. benzodiazepines; d. Glaucoma (open or acute narrow angle); e. Severe allergic reactions (e.g. anaphylactic reactions, angioedema 13. Subjects who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration or 5 half-lives of the investigational drug-whichever is the longer period. 14. Blood or plasma donation within 30 days prior to Screening 15. Subjects not willing or unable to tolerate blood draws. 16. Subjects who have received any other dosage form of diazepam or benzodiazepines within 2 weeks prior to entering Period A or Period B. 17. Consumption of alcohol within 48 hours before dosing and food or beverages containing grapefruit, star fruit, Seville oranges, and/or pomelo or their derived products (e.g., fruit juice) within 10 days prior to first drug administration. 18. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g. cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, or HIV antivirals) and strong inducers of CYP enzymes (e.g. glucocorticoids, St. John´s Wort, or rifampicin) in the previous 30 days before first drug administration [barbiturates, carbamazepine, and phenytoin are allowed since these are common AEDs (Anti-epileptic drugs)]. 19. Use of any monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine), phenothiazines (chlorpromazine) within 30 days prior to first drug administration. 20. Employee or immediate relative of an employee of the investigator, MonoSol Rx LLC, any of its affiliates or partners, or inVentiv Health | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 60.0-120.0, Osteo Arthritis Knee Criteria:• Patients undergoing primary TKR at the RD+E Hospital Patients must have completed a consent form for the study Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study Patient in whom any varus deformity present is <20° The diagnosis is of tricompartmental osteoarthritis of the knee Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) BMI<40 Aged =/> 60 years at time of surgery • Refusal to consent to the study If the knee for surgery has a fixed flexion deformity ≥15° this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery If the knee for surgery has a varus deformity ≥20° If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle <0° Pre-op Oxford Knee Score <8 Pre-op knee flexion ability <90° If the natural posterior tibial slope measured is in excess of 10° Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions Pregnancy | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Sleep Apnea Syndromes Epilepsies, Partial Male or female age ≥ 18 Patient suffering of pharmacoresistant epilepsy Frequency of epilepsy crisis : minimum 4 per month Antiepileptic drug on a stable dose for at least 2 months SA-SDQ score ≥ 25 Written informed consent obtained Patient affiliated with a social security regimen Pregnant females (female subjects who are lactating are not excluded) Anterior CPAP treatment Central apnea >20% during the initial polysomnography Mental retardation or severe cognitive impairment Presence of pseudo-crisis | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-70.0, Depression and Epilepsy Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards Known or unknown etiology (symptomatic or cryptogenic epilepsy) Psychogenic non-epileptic seizures Psychotic disorders and bipolar disorders | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-75.0, Epilepsy Depression At least 1 or more seizures with evidences demonstrated by EEG Severe psychotic symptoms such as hallucination and delusions Progressive central nervous system diseases such as acute stroke, brain malignant tumors, encephalitis, and Parkinson's disease etc Severe cardiac, pulmonary, hepatic, and renal diseases Severe cognitive dysfunctions and physical disabilities | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-50.0, Epilepsy Epilepsy, Temporal Lobe Participants will be between ages 18-50 years old Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments Willingness to participate and able to give informed consent If corrected vision: only Glasses should be used during the study testing History of significant head trauma Evidence of other neurologic disease Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism) Currently with lice or open wounds on scalp Significant sensory deficits Use of a hearing aid that occupies the ear canal Substance abuse in the last 3 months and any clinically significant substance dependency Additional for controls are a history of any neurological disease or psychological illness | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 1.5-16.0, Epilepsies, Focal Pediatrics Drug Resistant Epilepsy Drug resistant focal epilepsy for control patients without drug resistant focal epilepsy Severe mental retardation (IQ < 50) Lack of French-language skills Contraindications to MRI Bi-hemispherical epilepsy or affecting multiple lobes for control patients Severe mental retardation (IQ < 50) Lack of French-language skills Contraindications to MRI Congenital pathology altering cerebral connectivity Parenchymal brain lesions | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Post-Traumatic Headache Chronic Without Intractable Headache In order to be included in the study, you must be a person of either gender who is at least 18 years of age, meets of having had a traumatic brain injury, a physiological disruption of brain function, as manifested by at least one of the following: 1. . Any period of loss of consciousness 2. . Any loss of memory for events immediately before or after the accident 3. . Any alteration of mental state at the time of the accident (e.g., feeling dazed, disoriented, and confused) 4. . Focal neurologic deficits that may or may not be permanent Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (i.e. whiplash) without direct external trauma to the head Meets Internation Classification of Headache Disorders-version III (ICHD-III) for persistent post-traumatic headache which is defined as a headache of at least 3 months duration caused by a traumatic injury to the head Meets ICHD-III for episodic/chronic migraine, with or without aura (excepting for organic disease): 1. . Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) 2. . Headache has at least 2 of the following characteristics: 1. unilateral location 2. pulsating quality 3. moderate or severe pain intensity 4. aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs) 3. . During headache at least 1 of the following: 1. nausea and/or vomiting 2. photophobia and phonophobia A potential candidate for this study must be under the care of a physician for headaches and have an incomplete response to standard headache treatments Must have headache frequency of more than 8 days per month Must have a headache history of more than 6 months Must be able to attend or remotely participate (by video conference or telephone) in seven dietitian counseling sessions, and adhere to diet supplied to study participants Must be a Department of Defense (DoD) healthcare beneficiary and eligible to receive care at Walter Reed National Military Medical Center (WRNMMC), Fort Belvoir Community Hospital (FBCH) or Womack Army Medical Center (WAMC) A person cannot be in this study if they have a history of specific food allergies, especially to fish, dairy or gluten. Also exclusionary are Pregnancy or anticipated pregnancy Aversion to eating fish History of organic brain disorder other than TBI (vasculitis, encephalitis, meningitis, brain tumor) Major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorders, history of stroke or myocardial infarction Anticipated deployment or move to alternate location in the next 16 weeks Inability to read and communicate in English Regular use of fatty acid containing supplements Active or recent (2 years) history of treatment for substance abuse Cognitive impairment that prevents understanding of the protocol and completion of study procedures including compliance with the diet, blood draws and maintaining a daily headache diary | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 8.0-999.0, Epilepsy Intractable Focal Epilepsy > 8 years old intractable focal epilepsy presurgical evaluation or "phase 1" planified with focal EEG activity : more than 3 EEG interictal epileptic events per hour patient and/or legal representant given their written consent for their participation in the study MRI contraindication pregnancy uncomfortable prolonged lying position frequent primary or secondary generalised seizure with tonic clonic movements (>2 per week) previous epilepsy surgery important mental retardation | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-75.0, Epilepsy, Focal Seizures, Partial Seizures Key Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with multifocal epilepsy may be included if all other entry are met Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in combination) [Kwan 2010] Experiences 6 or more seizures during the 6-week prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period Key Focal aware seizures without motor signs are the only seizure type Diagnosis of generalized, combined generalized and focal, or unknown epilepsy Known progressive structural CNS lesion History of seizures occurring in predominantly clustered patterns, as determined by the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during the 6-week prospective baseline period, where individual seizures cannot be counted History of status epilepticus within the previous 6 months Known history or presence of non-epileptic seizures. NOTE; Other protocol defined Inclusion/ | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 22.0-99.0, Epilepsy, Motor Partial Psychogenic Seizures Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or Female between the ages 22 to 99. 4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing. 5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments. 6. Subject and/or Primary Caregiver must be competent to follow all study procedures. 7. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study Intracranial EEG electrodes are being used | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-21.0, Epilepsy Male or female children between 6-21 years of age undergoing an MRI for focal epilepsy at the Johns Hopkins Hospital OR ii. Adult healthy volunteer. iii. Willing to undergo an additional MRI exam in the 7T scanner at Kennedy Krieger Institute Presence of any contraindication to MR examinations as defined by MRI Safety Screening Sheet ii. History of Metal in the Skull/Eyes iii. Pregnancy at the time of the scan iv. Patient subjects in unstable clinical condition | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 2.0-999.0, Refractory Epilepsy Focal Epilepsy Focal Cortical Dysplasia Adult or pediatric patient suffering from drug-resistant focal epilepsy; Age more than 2 years old Brain MRI suggestive of FCD or normal; Standardized presurgical evaluation available including medical history, scalp video-EEG, 3T MRI, FDG-PET, Neuropsychological tests; Inpatient in one of the participating centers for recording seizure during long term scalp video-EEG and / or SEEG-monitoring; Resective surgery with a minimal post-operative follow-up of 12 months; Histopathologic evidence for FCD or non-pathologic findings (normal histology or mMCD type II) Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures Brain MRI suggestive of another type of lesion; Difficulty to read or understand French, or inability to understand the information Pregnant or breastfeeding woman Subject under judicial protection Other lesion discovered on histological examination; FCD type 3, dual pathology, ambiguous or unavailable neuropathological findings Lack of longitudinal pre and post-surgical follow-up | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-99.0, Severe Sepsis Patients > 18 yr. with diagnostic for severe sepsis, within 12 hours of admission in the Emergency Room, defined as hypotension after hemodynamic resuscitation, initial lactate > 4, or persistence of organ dysfunction (oliguria < 0.5 ml/kg/h, cyanosis, or altered consciousness).(qSOFA 1, 2 or 3) Patients who require immediate ventilatory support both invasive and non-invasive, defined by severe hypoxemia (PaO2/FiO2 < 150), severe tachypnea (40 x') with signs of respiratory fatigue or low level of consciousness (Glasgow < 8) Patients with limitation of the therapeutic effort or orders of not CPR Patients not susceptible to treatment with HFNC (facial trauma, tracheostomized, rejection of previous treatments with HFNC) Participation in other clinical trials that may affect survival Home treatment with oxygen, CPAP or Non-invasive ventilation | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Seizures Epilepsy Electrocardiography patients with epilepsy with a long-term video-EEG recording (or more) seizure (s) recorded onset seizure clearly defined on the basis of the EEG bad quality of the Electrocardiogram recording pace-maker non sinus rhythm | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Drug-resistant Epilepsy Focal-Onset Seizures Diagnosis of focal epilepsy per 1989 International League Against Epilepsy (ILAE) at least 3 years before study entry Subject has failed to achieve seizure control with 4 tolerated and appropriately chosen prior antiepileptic drugs (AED), including past and ongoing treatment, that were individually optimized for adequate dose and duration. Prior discontinued AED treatment would need to be assessed by the Investigator considering the patient medical records and patient and/or caregiver interview. 'Prior AED' is defined as all past and ongoing AED treatments with a start date before the Screening Visit (Visit 1) Average of >= 4 spontaneous and observable focal seizures (type IA1 (i.e. focal aware), IB (i.e. focal impaired awareness), IC (i.e. focal to bilateral tonic-clonic)) per month Current treatment with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit with or without additional Vagus Nerve Stimulation (VNS) or other neurostimulation treatments Subject has a history of or signs of generalized or combined generalized and focal epilepsy Cluster seizures which are uncountable in the previous 8 weeks before study entry and during 4 weeks prospective baseline Current treatment with carbamazepine, phenytoin, primidone, phenobarbital Current treatment/ use of (non-AED) prescription, nonprescription, dietary (eg, grapefruit or passion fruit), or herbal products that are potent inducers or inhibitors of the CYP3A4 or 2C19 pathway for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit Subjects taking sensitive substrates of CYP2C19 for 2 weeks (or 5 half-lives, whichever is longer) prior to the Baseline Visit Subject has been taking vigabatrin less than 2 years at study entry Subject has been taking felbamate for less than 12 months Subject taking retigabine for less than 4 years Current treatment with benzodiazepines (i.e. GABA-A-ergic drugs like zolpidem, zaleplon, or zopiclone, excluding GABA-A-ergic AEDs) <3 times per week for emergencies Subject has a current medical condition that occurred within the last 12 months which, in the opinion of the investigator, could compromise his/her safety or ability to participate in this study | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Epilepsy Hard-to-treat focal epilepsy 2. Aged 18 to 60 years 3. If female not pregnant Known clinical relevant structural cardiac disease 2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator 3. Use of beta blockers or other antiarrhythmic medication 4. Diagnosis of psychogenic non-epileptic seizures | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 40.0-80.0, Salt Hypertension From Excess Dietary Salt Lens Opacities Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure - | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Refractory Epilepsy Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital (none) | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-65.0, Partial Seizures With Secondary Generalization Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures) Focal onset seizures with secondary generalization; with or without primary generalized seizures ≥ 3 seizures/month on average within 3 months of enrollment Stable medication dosage for 3 months before enrollment Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images) Willing to maintain seizure diary (3 months before & 3 months after) Involved care provider Written informed consent to participate 65 years of age, inclusive Previous seizure work-up within 12 months of enrollment date to Low seizure frequency (<3 seizures/month) Previous vagal nerve stimulator Severe untreated neuropsychiatric disorders (untreated depression or behavioral problems) Recent history of drugs or alcohol abuse Generalized epilepsy (Lennox Gastaut, drop attacks) Post infectious epilepsy (post herpetic) Previous corpus callosotomy Significant structural brain abnormalities Unable or unwilling to maintain drug dosage for 3 months post treatment Pregnant or not practicing birth control method acceptable to the principal investigator | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-999.0, Focal Epilepsy Generalized Epilepsy Partial Seizures, Simple Subject aged 12 years or above 2. Subject has a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures 3. Subjects who have a baseline seizure rate of more than 2 per month in the eight week period preceding the start of AMPA / NMDA receptor antagonist 4. No seizure free period longer than 21 days during the eight week period before AMPA receptor antagonist was started 5. Patients who already had neuropsychiatric inventory completed twice during the treatment period spanning at least 16 weeks Subjects with idiopathic generalised epilepsy (for example, juvenile myoclonic epilepsy and absence epilepsy) 2. Patients who only suffer from isolated auras 3. Baseline creatinine clearance of less than 50ml/min 4. Severe hepatic impairment with ALT three times the upper limits of normal 5. Significant psychiatric conditions before the start of AMPA / NMDA receptor antagonist 6. Progressive neurodegenerative conditions 7. Active history of malignancy 8. History of severe haematological conditions or serious blood dyscrasias 9. Corrected QT interval more than 450 milli-second on ECG 10. Substance abuse 11. Pregnancy, breastfeeding | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 8.0-999.0, Seizures Epilepsy Epilepsy, Temporal Lobe Partial Epilepsy Age 8 years or older Known or suspected diagnosis of epilepsy Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child) If unable to give informed consent, ability to give assent (for minors 8 and older or adults without consent capacity) Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol Patients who are unable to travel to the NIH | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Subject is able to provide, personally signed, and dated informed consent to participate in the study or will have a legally authorized representative sign the informed consent on his or her behalf before completing any study related procedures. 2. Male or female ≥ 18 years of age. 3. Has an established diagnosis of focal or generalized epilepsy or focal and generalized epilepsy with a documented history of predictable seizure episodes that includes at least one of the following Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum duration of 5 minutes Episodes of a prolonged focal seizure with a minimum duration of 3 minutes Episodes of multiple (≥2) seizures within a 2-hour time period 4. Prior to randomization, has experienced ≥4 seizure episodes with predictable pattern during the last 4 weeks (qualification period) and no more than one week without a predictable seizure episode before entry into the in-patient unit. 5. Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner abstinence, birth control pills or patches, diaphragm with spermicide,intrauterine device (IUD), surgical sterilization, and progestin implant or injection. Prohibited methods the rhythm method, withdrawal, condoms alone, or diaphragm alone. 6. Subject is able to comply by the requirements of the protocol, particularly the requirements and specific Institution policies during the in-clinic stay History or diagnosis of non-epileptic seizures (e.g. metabolic or pseudo-seizures). 2. History of status epilepticus in the 6 months prior to Screening 3. Has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 3 months 4. Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g., etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease inhibitors (e.g., ritonavir) 5. Has severe chronic cardio-respiratory disease 6. History of HIV-positivity. 7. Pregnant or breast-feeding. 8. Clinically significant renal or hepatic insufficiency (hepatic transaminases >2 times the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN). 9. History of acute narrow angle glaucoma, Parkinson's disease, hydrocephalus, or history of significant head trauma. 10. Subjects who use medications to treat airways disease, such as asthma or COPD or have any acute respiratory signs/symptoms (e.g., wheezing). 11. Use of any investigational drug within 30 days or 5 half-lives of the investigational drug prior to administration of study medication, whichever is longer 12. A history within the past 1 year of drug or alcohol dependence or abuse. 13. Positive urine screen for drugs of abuse at Screening.(positive Cannabis/Cannabinol results are acceptable if there is a documented history of stable use for medical purposes). 14. Known allergy or hypersensitivity to alprazolam. 15. History of glaucoma. 16. Subjects who currently have an active major psychiatric disorder where changes in pharmacotherapy are needed or anticipated during the study. 17. Hypotension (systolic blood pressure ≤90 mm Hg, diastolic blood pressure ≤50 mm Hg), or hypertension (systolic blood pressure ≥140 mm Hg, diastolic blood pressure ≥100 mm Hg) measured while seated at screening or baseline. 18. Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease and congestive heart failure), endocrine, neurologic or hematologic disease. 19. Subjects who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the stability or capability of the subject to comply with the trial requirements | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-88.0, Epilepsy Seizure Disorder Clinical diagnosis of epilepsy using established Patient self-identified as own primary caregiver English fluency Ability to provide informed consent Ability to complete the study assessments History of non-epileptic seizures History of cognitive impairments that prevents them from providing informed consent and completing study assessments | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 3.0-14.0, Benign Childhood Epilepsy With Centrotemporal Spikes History and EEG findings of benign epilepsy with centrotemporal spikes Genetic disorders Metabolic or neurodegenerative disease Gross motor delay | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Osteoarthritis, Knee Osteoarthritis, Hip Key 1. A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit 2. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits 3. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments 4. A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip 5. History of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof Key History or presence at the screening visit of non-OA inflammatory joint disease (eg,rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy 2. History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation of collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period 3. Trauma to the index joint within 3 months prior to the screening visit 4. Signs or symptoms of carpal tunnel syndrome within 6 months of screening 5. Patient is not a candidate for MRI Note: Other protocol defined Inclusion/ apply | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Heart Failure, Congestive Willing and able to make use of a smartphone and to give informed consent for participation to the study Ischemic or non-ischemic heart failure disease Functional New York Heart Association (NYHA) class 2-3 Reduced left ventricular ejection fraction ≤40% Ambulatory heart failure patients in stable condition: at least one hospitalization due to their heart failure once, but no hospitalization during the month before start of the trial and no planned surgery Good cognitive function, if cognitive impairment is suspected the patient will be evaluated by using the Mini Mental State Examination (MMSE) Sufficient knowledge of the native language (Dutch in Belgium, Italian in Italy) Heart failure patients who fulfill the above mentioned but suffer from a concomitant end-stage chronic kidney disease necessitating haemodialysis Heart failure patients who fulfill the above mentioned but are already participating in a disease management program, influencing the HeartMan intervention | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Cardiac Arrest An out-of-hospital cardiac arrest with return of spontaneous circulation Ventricular fibrillation or ventricular tachycardia as first registered cardiac rhythm Glasgow Coma Scale (GCS)-score ≤8 Patients with pre-existent terminal renal insufficiency Known glucose 6-phosphate dehydrogenase deficiency (risk of hemolysis) History of urolithiasis, oxalate nephropathy or hemochromatosis Treatment limitations | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy All consecutive adult patients (i.e. aged at least 18 years) with focal epilepsy in whom BRV was introduced (no more than 48 hours prior to their time of recruitment) at participating medical centres, ambulatory or hospitalized, will be approached to participate in the study We will individuals with generalized epilepsy as well as those aged less than 18 years, in order to respect current Health Canada indications. We will individuals cognitively or physically unable to complete the study questionnaires | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-65.0, Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Biomarkers Age ≥ 16 years and ≤ 65 years at time of enrollment 2. Diagnosed with focal epilepsy with prior vEEG confirmation; if no VEEG confirmation, but in the opinion of the investigator the seizures are definite, the case can be reviewed and adjudicated by the consortium 3. Failure of adequate trials of 4 AEDs, with at least 2 due to failure of seizure control, including current AEDs 4. Have a seizure frequency of ≥ 2 focal seizures/month, including auras, and at least 1 observable seizures/month, that are countable by the subject and/or caregiver for the 3 months prior to enrollment 5. Able to keep a daily seizure diary, either independently or with assistance from a caregiver 6. Able to retrospectively report number of seizures/month for 3 months prior to enrollment 7. Receiving ≥ 1 AED for treatment of seizures Patient has a diagnosis of idiopathic ("primary") generalized epilepsy (e.g., juvenile myoclonic epilepsy, absence epilepsy) or mixed focal and generalized (e.g., Lennox-Gastaut syndrome) or non-epileptic seizures within the last 12 months prior to study entry 2. Progressive medical or neurological disorder (brain tumor, AD, PME, etc.) 3. Proven autoimmune etiology 4. Planning pregnancy in the next 12 months 5. Has completed a pre-surgical evaluation and intends to pursue surgery in the near term 6. Resective surgery and/or RNS/VNS in place less than 12 months prior to enrollment 7. Presence of moderate or greater developmental or cognitive delay (e.g., if an adolescent, not in self-contained classroom; if IQ is documented, should be ≥ 70) 8. History of chronic drug or alcohol abuse (misuse or excessive use that interferes with activities of daily living) within the last 2 years 9. Medical, psychiatric or psychosocial condition that would be expected to interfere with the conduct of the study 10. Enrolled in any interventional study that required a blinded portion or involves a non-FDA approved drug or device | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Epilepsy Patients with epilepsy who are participating in Brivaracetam (BRV) studies N01125, N01199, N01372, N01379 or N01315 Patients for whom the treating physician believes there is a continued benefit from the long-term administration of BRV and other anti-epileptic therapies might not be suitable for the patient Female patients without childbearing potential are eligible Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the Compassionate Use Program (CUP) participation. The patient must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and inform the treating physician of any potential change in status Patient is considered reliable and capable of adhering to medication intake Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if required under local regulations, has given written informed consent Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behavior, or laboratory values which may have an impact on the safety of the patient, as determined by the treating physician Poor compliance with medication intake in the previous BRV study Participation in any clinical study of another investigation drug or device during the CUP Pregnant or lactating woman | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 6.0-25.0, Rolandic Epilepsy Diagnosis of Rolandic Epilepsy in accordance with the following international Age of first afebrile seizure 3-12 years Seizures comprising focal sensorimotor seizures affecting the vocal tract and face, with or without involvement of the arm Predominant sleep-related seizures EEG interictal centro-temporal spikes with normal background 2. Current age 6-25 years No history of focal seizure 2. Normal EEG or abnormal background features on EEG 3. Known structural causes (stroke, tuberous sclerosis, infection, post-infectious or metabolic) 4. Primary diagnosis of autism or global learning disability 5. Focal central neurological deficit on clinical exam, 6. Unable to provide informed consent 7. Unable to provide blood sample | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-24.0, Self-Control Healthy college-age youth between the ages of 18 and 24 years Gross impairment of vision or hearing Inability to read and follow written instructions Physical, neurological, or concurrent psychiatric impairments Regular intake of psychotropic medication (such as methylphenidate used to treat Attention Deficit Hyperactivity Disorder (ADHD), antidepressants, or anti-anxiety medication) A history of head injury that resulted in loss of consciousness/a history of brain surgery/or seizures A current/past history of smoking and/or alcohol or drug abuse (i.e., five or more drinks in one sitting or 15 drinks or more during a week for men, and four drinks on one occasion or eight drinks over the course of a week for women; additionally, regular drug use, including marijuana) Current pregnancy Any metallic objects in your body (such as braces, pacemakers, surgical devices, piercings that cannot be removed etc.) Enrollment of the subjects will start in May 2018 and will be finished by the end of December 2018 | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 5.0-999.0, Epilepsy Previous diagnosis of Epilepsy or other seizure disorder Admitted for scheduled EEG testing with a minimum of overnight (24 hour) EEG years of age through adult Known or suspected allergy to adhesives | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 16.0-999.0, Alcohol Withdrawal Delirium Alcohol Withdrawal Alcohol Withdrawal Seizures Alcohol withdrawal syndrome (regardless of admitting diagnosis). 2. Severe symptoms, as defined by a 'Clinical Institute for Withdrawal Assessment Adult revised' (CIWA-Ar) score of 16 or more, or delirium severe enough to prohibit assessment with the CIWA-Ar, or observed withdrawal seizures, in each case despite treatment with at least 60 mg of diazepam (or an equivalent dose of another benzodiazepine) in the previous 16 hours, regardless of route of administration.. 3. Early alcohol withdrawal, broadly defined as the first 16 hours after the diagnosis of acute alcohol withdrawal has been made. The time of diagnosis will be taken to be the time of prescription of symptom-triggered benzodiazepine therapy ("CIWA protocol"), or the time of consultation to ICU/Emergency Department, Internal Medicine, or the Addictions Service (Psychiatry) for the management of alcohol withdrawal. 4. Anticipated need for hospitalization (i.e. admission to ICU, medical step-up unit, or wards) an alternate etiology for delirium thought to be more likely than alcohol withdrawal; 2. age <16 years; 3. pregnancy (positive assay for ßhCG). A urine assay or blood test will be performed for all women < 55 yrs; 4. current breastfeeding; 5. severe acute hepatitis (AST or ALT >500); liver failure (INR >2 not otherwise explained); 6. a presenting complaint of neurotrauma, brain mass, or intra-cranial bleed; abnormal cell count or gram stain on lumbar puncture (if performed); 7. strong clinical suspicion of recent co-ingestion of depressant drugs (e.g. opioids, toxic alcohols, gamma-hydroxy-butyrate); 8. hemodynamic instability (systolic blood pressure [SBP] < 90 mmHg); 9. history of barbiturate allergy; 10. history of porphyria; 11. history of myasthenia gravis; 12. inability to obtain IV access; 13. anticipated transfer to another centre; 14. stated intent to leave against medical advice; 15. active outpatient prescription for anti-retroviral therapy for HIV 16. active outpatient prescription for one of the following anti-epileptic drugs: valproic acid, phenytoin, carbamazepine, clobazam, lacosamide, lamotrigine, levetiracetam, topiramate, primidone, or phenobarbital. 17. active outpatient prescription for an anticoagulant medication with a significant metabolic interaction with phenobarbital (i.e. warfarin or apixaban). 18. active outpatient prescription for a monoamine oxidase inhibitor (e.g., phenelzine, selegiline, tranylcypromine, isocarboxazid) 19. renal failure, as defined by a creatinine clearance <10 mls/minute (as calculated by Cockcroft-Gault equation) and/or active receipt of renal replacement therapy (dialysis). 20. administration of IV or oral phenobarbital during the index admission prior to randomization | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Generalized Epilepsy All patients with the clinical diagnosis of generalized epilepsy with generalised onset motor seizure (ILAE 2017) with a history of an episode of seizure within 72 hours of presentation Patients aged 18-60 years, of either sex Treatment-naive patients or patients who had not taken any treatment for at least 4 weeks before inclusion History of any recent traumatic brain injury, cerebral ischemia/TIA/stroke Patients with neuroendocrinal tumors History of any invasive neurosurgical/non-invasive neuropsychiatric procedure Patients who are already under treatment for the presenting conditions Medication history of psychoactive or central nervous system depressant drugs Pregnant and nursing women Patients with a history of allergy to valproate, melatonin or other melatonin agonists Patients with drug/alcohol abuse Patients with any hepatic dysfunction | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Anesthesia Male or Female subjects 18 years of age or older English or Spanish Speaking Subjects who have been previously diagnosed with intractable epilepsy and require implantation of invasive electrophysiological recordings as part of their routine clinical presurgical workup Patients with skin abnormalities at the planned application sites that would interfere with sensor or electrode applications Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI) Patients who the PI deems ineligible at the PI's discretion Pregnant patients | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Refractory Epilepsy Patient, male or female, over 18 years old Glioma confirmed by histology Not in progression (clinico-radiological criterion RANO, (Wen et al., 2014), see appendix 1) No clinical worsening (excluding epileptic seizures) No increase greater than 25% in contrast enhancement after gadolinium injection No increase in the T2 / FLAIR hyper signal Absence of new lesion Diagnosis of drug-resistant epilepsy according to international epilepsy definitions (Fisher 2014 and Kwan 2010, see Appendices 2 and 3) o Repeated epileptic seizures despite testing of two effective dose antiepileptic drugs tried at least 3 months With at least 2 attacks per month (to ensure visibility on the duration of the study of the antiepileptic effect, see below) Patient with epileptic seizures not limited to only subjective signs Pregnant or lactating woman Minor Impossibility of signing consent No affiliation to a social security scheme (beneficiary or beneficiary) Person in emergency Person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his or her consent Patient with at least 2 generalized tonic-clonic seizures per month | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-65.0, Epilepsy Patient or pediatric patient suffering from drug-resistant focal epilepsy Standardized presurgical evaluation including medical history, scalp video-EEG, 3T MRI (DTI and rsMRI), FDG-PET, Neuropsychological tests Inpatient in one of the participating centers for recording seizure during long term SEEG-monitoring Epilepsy surgery performed without the requirement of SEEG or contra-indication to epilepsy surgery | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 12.0-999.0, Temporal Lobe Epilepsy patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study based on the following Clinical features consistent with seizures of temporal lobe origin Focal ictal temporal lobe patterns recorded with EEG No lesion detected by conventional MR imaging other than mesial temporal sclerosis Any general contraindication of MRI in some cases as presence of para magnetic substance as pacemakers or in patients with claustrophobia Subjects with age less than 12 year old Patients with any structural lesion other than mesial temporal sclerosis identified on MR brain imaging | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.0-999.0, Epileptic Encephalopathy of Unindentified Genetic Origin Diagnosis of epileptic encephalopathy, defined by the clinical association of epilepsy and a significant delay in acquisition Family case with recurrence in siblings, suggesting autosomal recessive transmission or X-linked inheritance (with or without parental consanguinity), or sporadic case resulting from inbreeding Lack of etiologic orientation based on clinical examination Normal routine diagnostic genetic examinations including a metabolic check-up, array CGH analysis Brain imaging which does not suggest an acquired cause Unavailable parental samples Diagnostic orientation from one of the tests mentioned above Brain imaging suggesting anoxia sequelae | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-999.0, Epilepsy Adults ( >18 years) diagnosed with epilepsy who live with a dog Children (< 18 years) that have been diagnosed with epilepsy and live with a dog; represented by the parents Epilepsy patients with intellectual disabilities that live with a dog; represented by their legal representative Participants or their representative must be able to answer questions using our online questionnaire. They must sign the inform consent to access the questionnaire | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-60.0, Low Intensity Ultrasound Pulsarions Male and female subjects, 18 to 60 years old Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity, confirmed via intracarotid amobarbital procedure (IAP) and neuropsychological testing Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs Subjects currently taking antiepileptic medications Subjects with at least 3 seizures/month based on seizure diary Subjects with epilepsy who would clearly benefit from surgical intervention Subjects who have been offered an anterior-mesial temporal lobe resection, performed en-bloc, as treatment for medication refractory epilepsy. This includes both dominant or non-dominant mesial temporal lobe focal epilepsy Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing Subjects with dementia, delirium and psychotic symptoms Subjects with ferromagnetic materials in the head Subjects with severe cardiac disease, increased intracranial pressure, or a transcutaneous electrical nerve stimulation (TENS) unit Subjects who exhibit primary generalized seizures or pseudoseizures Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease Subjects who have experienced status epilepticus during the 3-week period prior to the LIFUP procedure Subjects (females) who are pregnant Patients who have had electrodes implanted in the brain that were not explanted at least 6 weeks prior to the LIFUP procedure Patients who have had electrodes implanted into the focal point of the temporal lobe that is proposed for the ultrasonic stimulation using LIFUP | 1 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 18.0-63.0, Whiplash Injuries Study population The for patients are Chronic neck problems corresponding to WAD grades 2-3 verified by clinical examination Average estimated pain in the last week at least 20 mm on the visual analogue scale (VAS) Neck disability of more than 20% on the Neck Disability Index (NDI) [10] Working age (18 years) Daily access to a computer/tablet/smart phone and Internet Neck symptoms within the first week after the injury (i.e., neck pain, neck stiffness, or cervical radiculopathy). For the present sub group study additional were Right handed Dominant right sided or equal sided pain for healthy controls: • Age and gender matched healthy individuals without neck pain and disability (VAS <10mm, NDI <5%) that feel overall healthy without known diseases for patients Individuals with any of the following signs of head injury at the time of whiplash injury will be excluded: loss of consciousness, amnesia before or after the injury, altered mental status (e.g., confusion, disorientation), focal neurological changes (changes in smell and taste) Previous fractures or dislocation of the cervical spine Known or suspected serious physical pathology included myelopathy Spinal tumours Spinal infection Ongoing malignancy Previous severe neck problems that resulted in sick leave for more than a month in the year before the current whiplash injury surgery in the cervical spine Generalized or more dominant pain elsewhere in the body | 0 |
41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe. The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation. Past Medical History: Epilepsy as above, CHF, depression | eligible ages (years): 0.673-999.0, Neonatal Abstinence Syndrome Infants greater than or equal to 35 weeks gestation age Admitted to the neonatal intensive care unit Failed monotherapy with morphine sulfate therapy Neonatal abstinence syndrome due to iatrogenic causes Unable to take oral medications at any point during their treatment Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment | 0 |
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