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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): 70.0-999.0, Sedative Adverse Reaction Anticholinergic Adverse Reaction Age ≥70 years old DBI score >0 (taking ≥1 regular medication with a sedative or anticholinergic effect prior to admission) Informed consent able to be obtained from patient or substitute decision maker as per hospital policy Able to communicate in English (as DBI report only available in English) Expected discharge within 24 hours of recruitment or 48 hours of admission Terminal phase of illness (expected to die during current admission) OR noted to be 'palliative care' Usual residence outside Nova Scotia | 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 all patients undergoing a stereo-electro-encephalography (SEEG), age 12 to 65 years old usual excluding for a SEEG | 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, 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): 6.0-13.0, Hearing Impairment Hearing Loss, Sensorineural children ages 6 to 13 years English as the primary home language positive for bilateral symmetrical mild to moderately-severe sensorineural hearing loss currently using hearing aids that were dispensed at least 18 months prior to enrollment of the study negative for major cognitive handicap or developmental delay that would prevent or restrict participation, as determined by the PI or designee negative for learning disability, for example attention-deficit/hyperactivity disorder, as determined by the PI or designee negative for serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee informed consent of parent/guardian assent of participating child if aged 11 years and over standard MRI as set by the Cincinnati Children's Hospital Medical Center department of Radiology | 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): 3.0-15.0, Autism Spectrum Disorder Autism Confirmed diagnosis: autistic type disorder (ASD) Systemic speech underdevelopment The presence of attention deficit hyperactivity disorder as a comorbid state Cognitive impairment organic pathology of the brain according to CT, MRI the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases decompensation of chronic and endocrinological diseases acute respiratory viral and bacterial infections, period less than 1 month after the acute phase HIV infection, hepatitis B and C oncological diseases, chemotherapy in the anamnesis tuberculosis Severe form of intellectual disability Cerebral palsy epilepsy | 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, Alcohol Withdrawal Syndrome Primary admitting diagnosis of acute alcohol withdrawal syndrome based on International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), code F10.3, F10.4 Significant comorbid medical illness requiring Intensive Care Unit admission Pregnancy Inability to obtain intravenous access Child Pugh Class C; and Allergy to study medications (phenobarbital, ketamine, lorazepam) | 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): 5.0-18.0, Hemiparetic Cerebral Palsy • Age 5 years Hemiparetic Cerebral Palsy (perinatal brain injury) Intelligence Quotient >70 (Binet Kamat Test/Malin's Intelligence Scale for Children) Modified Ashworth scoring 1-3 for affected limb Can sit independently or with support (GMFCS stage : 1-4 and Manual Ability Classification System stage: 1-3) Preserved vision and hearing (with or without correction) • Uncontrolled epilepsy as defined by seizure frequency >1/month for preceding 3 months Severe concurrent illness or disease not associated with CP or unstable medical conditions like pneumonia Genetic or syndromic associations Children diagnosed with Autistic Spectrum Disorders Modified Ashworth Scale Score more than 3 at shoulder/elbow/wrist Contractures of affected limb Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement Any congenital brain malformation detected on conventional MRI brain Recent surgery/cast/splint in affected limb Botulinum toxin/phenol block in affected limb in past 6 months or planned to receive in study period | 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): 10.0-120.0, Epilepsy patients referred to the participating centers on suspicion of epilepsy none | 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): 18.0-999.0, Healthy Subjects Biobank participants who receive the majority of their care at Mayo Clinic based on EHR length and depth Not in the Mayo Clinic Biobank. Do not receive the majority of their care at a Mayo Clinic site | 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, Sepsis, Severe A written, signed informed consent, by the patient or the patient's legally authorized representative 2. Participants with an absolute lymphocyte count (ALC) ≤ 900 cells/mm3, at two time points at least twelve hours apart, following diagnosis of vasopressor dependent sepsis and, 1. the second time point should not be performed earlier than 48 hours after sepsis diagnosis, 2. study drug treatment initiation is required no later than 120 hours (up to 5 days) after the last qualifying ALC ≤ 900 cells/mm3 measure, and 3. the average value of the two qualifying ALC counts will serve as a baseline to express the percent increase at day 29, or at hospital discharge. 3. Patients in the ICU with onset of vasopressor dependent sepsis defined as hypotension requiring treatment with any vasopressor(s) for at least 6 hours to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥65 mmHg AND at least 1 of the 2 organ dysfunction below: 1. Acute respiratory failure defined as the need for invasive mechanical ventilation for at least 24 hours to support pulmonary function 2. Acute kidney injury defined as creatinine > 2.0 mg/dL (based on new abnormal result following onset of sepsis) OR urine output < 0.5 mL/kg/hr for > 4 hours despite adequate fluid resuscitation. In the presence of pre-existing impairment of renal function (defined as a serum creatinine concentration >2 times the upper limit of the normal reference range prior to the onset of sepsis), the patient must meet the other organ dysfunction criteria. 4. Anticipated hospital duration of up to approx. three weeks after initiating study drug treatment to allow 6 study drug administrations (Days 18 or 19 would be final dose) 5. This study permits the re-enrollment of a participant who may have been discontinued as a pre-treatment screen failure and/or prior to study drug treatment. 6. Age and reproductive status: 1. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment 2. Women must not be breastfeeding 3. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 (the terminal half-life of CYT107 is up to 2 days) plus 30 days (duration of ovulatory cycle) for a total of 2 months post-treatment completion. 4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with CYT107 plus 5 half-lives of CYT107 plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. 5. Azoospermic males are exempt from contraceptive requirements. 6. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements but still must undergo pregnancy testing Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 weeks). All patients with current, or history of, hematologic malignancy (including, but not limited to, ALL, AML, CLL, CML, etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy 2. Patients with minimal chance of survival and life expectancy less than 3-5 days as defined by an II score of ≥ 35 at time of consideration for study 3. Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc. 4. Patients who have received a solid organ transplant or bone marrow transplant. 5. Patients with active or a history of acute or chronic lymphocytic leukemia 6. AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry 7. Known history of chronic HBV infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization or HBV DNA > 100 IU/mL 8. Known history of infection with HCV and currently undergoing treatment for HCV infections or has detectable HCV RNA 9. Known history of tuberculosis and currently undergoing treatment for tuberculosis 10. History of splenectomy 11. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia 12. Participation in another investigational interventional study testing a drug or a medical device within the last 3 months prior to study entry 13. Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for any reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day 14. Patients receiving concurrent immunotherapy or biologic agents; including growth factors, cytokines and interleukins other than the study medication : IL-2, Interferons α, β and γ, GM-CSF, G-CSF, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy 15. Prior exposure to IL 7 or other drugs specifically targeting T cells 16. Presence of an advanced directive to withhold or withdraw life-sustaining treatment, DNR order or no CPR order, or comfort measures only order 17. Patients for whom prognosis is poor and source control of septic event is considered unlikely per the clinical and research teams. 18. Patients under 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): 18.0-60.0, Pain, Postoperative Anesthesia Thoracotomy ASA I-II BMI 18-28kg/m2 Wedge incision and lobectomy Uncontrolled hypertension or chronic conditions History of opioid dependence Allergy to bupivacaine hydrochloride Severe bleeding during operation or post operation Inability to communicate with investigators | 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, Adrenomyeloneuropathy X-linked Adrenoleukodystrophy Clinical signs of AMN with at least pyramidal signs in the lower limbs and difficulties to run Presence of motor deficit according to the EDSS scale Ability to perform the 2MWT Normal brain MRI or brain MRI showing abnormalities that can be observed in AMN patients without cerebral form of X-ALD with a maximum Loes score of 4 Ejection fraction > 50% at echocardiogram Normal electrocardiogram Normal urine cytology Normal liver function, as assessed by plasma ASAT, ALAT, PAL, γGT, bilirubin measures (≤2.5-fold normal values) Normal kidney function as assessed by plasma urea, creatinin (≤ 2-fold normal values) Appropriate steroid replacement if adrenal insufficiency is present Gadolinium enhancement on T1 sequence of any abnormal hypersignal of white matter, including myelinated pyramidal tracts, visible at brain MRI on FLAIR sequences Brain MRI abnormalities of the "AMN type" with a Loes score > 4 Any abnormal hypersignal of white matter visible on FLAIR sequences other than of "AMN type" and related to X-ALD Patients taking pioglitazone or another glitazone during the past 6 months Diabetic patients (type I or II) Fasting blood glucose > 125 mg/L Glycosylated hemoglobin > 6% History of heart failure Heart failure (NYHA III to IV) or ejection fraction ≤ 50% History of cardiac disease | 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 Subjects at least eighteen (18) years of age Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing Subjects with dementia or other progressive degenerative disease, delirium or active psychosis 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 have primary generalized epilepsy or non-epileptic seizures Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still) Subjects with current brain tumors or an intracranial vascular lesion Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation | 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 Patients selected to undergo anterior thalamic nucleus DBS for refractory epilepsy Contraindication to MRI | 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, Depressive Symptoms Epilepsy, Temporal Lobe Patients older than 18 years. 2. Diagnosis of Temporal Lobe Epilepsy based on clinical, electrophysiological, magnetic resonance (MRI) and computed tomography (CT) imaging of the brain. 3. Patients will be selected who are able to adequately complete the self-administered questionnaires and handle the home tDCS equipment. 4. 13 points or more on the Beck Depression Inventory Clinical history suggestive of other paroxysmal abnormalities other than temporal lobe epilepsy, such as syncope, psychogenic seizures, or transient vascular accident; 2. Change in the antiepileptic regime in the last 30 days; 3. History of status epilepticus on last year; 4. Performed vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS) or other neurostimulation <1 year prior to study; 5. Active suicide plane; 6. Contraindication for tDCS, including head injury, metal on the head or any implanted medical device, including pacemakers and cardiac defibrillators; 7. 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): 55.0-999.0, Mild Cognitive Impairment Dementia of Alzheimer Type Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT) 2. Must be MRI compatible, that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head) 3. Stable on relevant medications for at least 4 weeks prior to study enrollment Certain neurological diseases 2. Certain psychiatric conditions 3. Severe sensory impairment | 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 patient whose age ≥ 18 years Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph Diagnosis of primary or secondary brain tumor, radiologically and / or histologically Epilepsy revealing or occurring in a patient developing a brain tumor Francophone patient Pre-existing and known epilepsy before the diagnosis of brain tumors Epilepsy occurring within 2 weeks postoperatively Anteriority of taking antiepileptic treatment Patient under tutorship or curatorship Patient deprived of liberty Patient with comprehension disorders making it impossible to understand the protocol Patient or relative opposing the use of his data | 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): 20.0-999.0, Hip Fractures Cognitive Impairment Subjects are: 1. age 60 years or older, 2. admitted to CGMH due to one-side hip fracture, and being diagnosed as needing surgery, 3. assessed as having cognitive impairment by the Chinese Mini-Mental State Examination (CMMSE) (CMMSE score < 21 with < 6 years education, or CMMSE < 25 with ≥ 6 years education; Yip et al., 1992), 4. having a primary family caregiver, 5. living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju province) Family caregivers: 1. age 20 years or older, 2. responsible for providing direct care to or supervising care received by the patient Subjects are 1. cognitively intact by CMMSE, 2. without a primary family caregiver, 3. terminally ill, 4. severe cognitive impairment such that they are completely unable to follow orders (CMMSE < 10; Yip et al., 1992) | 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 Focal (partial) onset seizures that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video electroencephalogram (EEG) that captured at least one ictal event Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness Age 18 or older at the time of enrollment Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff Able to use the Patient Programmer with or without the assistance of a caregiver Ability of the subject or legal representative to understand and provide signed consent for participating in the study Willing and available to attend visits as scheduled and to comply with the study protocol Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification) Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit Previous diagnosis of psychogenic/non-epileptic seizures Surgical candidate for and willing to undergo resective surgery Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas) Diagnosed with a progressive or degenerative neurological disorder affecting the brain Significant medical condition that may impact study participation in the opinion of the investigator Presence of any of the following within 1 year prior to the Enrollment Visit: psychiatric illness hospitalization, suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a medication Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas) | 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): 10.0-19.0, Dental Anxiety Brazilian adolescents literate in Portuguese Brazilian adolescents able to use smartphone Adolescents with intellectual, sensory or physical disabilities Adolescents not capable to read and write/type | 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, Aphasia Presence of post-stroke aphasia Single left hemisphere stroke etiology At least 6 months post-stroke Age range between 18 and 80 years old Speak English as a native language Adequate hearing and vision to complete the tasks Severe auditory comprehension deficits (determined by pretest) (i.e., global aphasia, Wernicke's aphasia, transcortical sensory aphasia) Inability to provide informed consent Co-occurring history of neurological disease/disorder/injury (e.g., traumatic brain injury, right hemisphere stroke, dementia) Co-occurring history of a major mental illness (e.g., schizophrenia, drug addiction, bipolar) Clinical conditions contraindicated for MRI or tDCS (e.g., implanted electrical devices, claustrophobia, seizure disorder) Positive pregnancy test (for females) | 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): 14.0-65.0, Epilepsy, Temporal Lobe Clinical diagnosis of drug resistant epilepsy At least one or more anti-epileptic drugs (AEDs) regular administered for more than 2 years, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month 14 years or older at enrollment Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier Auras that occur in isolation and are not primary sensory other than olfactory or gustatory I.Q. of greater than 70 Hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging Interictal EEG shows focal or lateralized spikes on temporal, frontal zone, or sphenoid electrode Ictal EEG onset is focal or lateralized on the ipsilateral side Ipsilateral temporal focal hypometabolism on PET Must be agreed by a consensus of ipsilateral mesial temporal origin by a multidisciplinary discussion Must be able to understand and speak Mandarin A history of serious cerebral insult after the age of 5 A progressive neurological disorder; mental retardation (I.Q. less than 70) Psychogenic seizures Focal neurological deficits other than memory disturbances Any unexplained focal or lateralized neurological deficits other than memory dysfunction. Temporal neocortical or extratemporal lesions on MRI Psychosis, current or recent substance abuse, suicidality, anorexia, or psychogenic seizures Severe systemic diseases Unequivocal focal extratemporal EEG slowing or interictal spikes Lesions on MRI outside of the mesial temporal area Diffuse unilateral or bilateral hypometabolism on positron emission tomography (PET) Contralateral or extratemporal ictal onset Persistent extratemporal, or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes Patient who was included in any clinical trial Pregnancy | 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 epilepsy, including seizures with and without impairment of consciousness, and secondarily generalized seizures Disabling seizure counts >3 per month (Disabling seizures are those with significant negative impact on the patients life) Drug resistance to >2 appropriate seizure drugs with therapeutic serum concentrations Not a good candidate for resective surgery or at significant risk for verbal memory decline as determined by our institution's multidisciplinary Epilepsy Surgery Committee For 3 months prior to enrollment, subject's anti-seizure medication dosages have been stable and subject has had at least 6 disabling (as defined in 1) seizures per month, on average, with a seizure-free interval not to exceed 30 days. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster of seizures, for the purpose of this criterion, shall be considered a single seizure With the exception of epilepsy, subject must be medically and neurologically stable Mayo Clinic Epilepsy Surgery Committee approval for brain stimulation therapy obtained on clinical grounds and without reference to this protocol Age 18 to 75 Ability and willingness to provide informed consent and participate in the study protocol. Subject is able to interpret and to respond, in accordance with the study protocol, to the advisory indicators provided by the device Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver For 3 months prior to enrollment, subject's anti-seizure medication dosages have not been stable, or subject has had more than 25 disabling (as defined in 1) seizures per month, on average, or there was a seizure-free interval longer than 30 days within the past 3 months. Clinical seizures must be separated by a minimum of eight hours to not be considered part of a cluster. Cluster seizures are considered a single seizure event Subject has a contraindication to magnetic resonance imaging Subject has a substance abuse history (alcohol, prescription, or illicit medications) within the preceding two years Subject participated in another drug or device trial within the preceding 30 days Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis) Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the RC+S device. This includes, but is not limited to, direct brain neurostimulators, spinal cord stimulators, vagus nerve stimulators (VNS), and cochlear implants. Patients with a vagus nerve stimulator implanted but turned off through the duration of the study may be enrolled, provided their clinical status has been stable for at least one month with VNS turned off. Alternatively, patients with a VNS may have the previously disabled VNS removed at time of surgery to implant the Medtronic RC+S Subject has been diagnosed with psychogenic or non-epileptic seizures Subject has been diagnosed with primary generalized seizures Subject has experienced unprovoked status epilepticus in the preceding year Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement | 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): 40.0-999.0, Osteoarthritis of the Knee Pain Key Generally in good health at the screening visit Body mass index (BMI) ≤39 kg/m2 at the screening visit Clinical diagnosis of OA of the knee on the American College of Rheumatology (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit Moderate-to-severe pain in the index joint A history of inadequate pain relief from or intolerance to analgesics used for OA Key Diagnosis of systemic diseases that may affect joints History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader Is scheduled for a joint replacement surgery to be performed during the study period Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted) History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit 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, Low Back Pain Adults 18 years of age or older Have LBP for more than 6 months Previous low back surgery, systemic joint disease (e.g. rheumatoid arthritis) Fracture Infection Tumor or cancer Cauda equina syndrome neurological disorders Neuropathy Raynaud's Disease pregnancy Inability to maintain the testing and treatment positions (i.e. sitting, supine hook-lying and prone-lying) for 15 minutes at a time | 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): 18.0-100.0, Epilepsy, Post-Traumatic Acute Traumatic Brain Injury (TBI) Age 18-100 are eligible Glasgow Coma Scale (GCS) 3-13 without continuous sedation at time of enrollment Ability to enroll within 72 hours of injury Hemorrhagic contusional injuries to frontal and/or temporal lobes Polytrauma including long bone fractures, blunt trauma, abdominal trauma or similar will be allowed Penetrating TBI if continuous electroencephalography (cEEG) is feasible and survival for 2 years is feasible, recognizing that MRI may not be feasible with some forms of penetrating trauma Low-affinity TSPO binding profile Ages 17 years or younger Patients with diffuse axonal injury in the absence of hemorrhagic contusions or skull fracture, and isolated epidural hemorrhages that improve after evacuation No planned continuous EEG monitoring during injury day 1-7 Inability to undergo MRI at 14 days (± 4 days) due to bullet, metal implant, or pacemaker Pregnancy Pre-existing Neurodegenerative Disorders Pre-existing epilepsy/seizure disorder Pre-existing dementia Isolated anoxic brain injury | 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, Alzheimer Disease Meet the National Institute of Aging-Alzheimer's Association for probable AD Twelve-item Neuropsychiatric Inventory with score 4 or greater MMSE <26 Stable doses current medications, including acetylcholinesterase inhibitors if applicable, for at least 4 weeks prior to trial entry Reliable caregiver willing and available to assist with medication administration, outcome measures MRI completed with no evidence of potential seizure focus as outlined in the Imaging suggestive of potential seizure focus or alternative cause of dementia Previous Epilepsy diagnosis Use of anti-epileptic medication for any indication within previous three months History of head trauma with loss of consciousness more than 30 minutes Alcohol/Substance abuse within 5 years of dementia onset or previous 5 years History of Korsakoff's syndrome History of encephalitis/meningitis Female participant who is pregnant, lactating or planning pregnancy during trial Scheduled elective surgery or other procedures requiring general anesthesia during the trial Participant with life expectancy of less than 12 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, Arachnophobia Phobia At least 18 years of age 2. English-speaking 3. Spider phobia as determined by a Spider Phobia Questionnaire (SPQ; Klorman et al 1974) score of at least 17/30 Subject is mentally or legally incapacitated, unable to give informed consent. 2. Subjects with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded. 3. Subjects with a HamD suicidality item score of '3' or '4,' corresponding to "suicidal ideas or gestures" or "attempts at suicide," will be excluded. 4. Subjects with exposure to ECT within the past 6 months, previous TMS treatment for any condition, or VNS treatment (lifetime). 5. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis. 6. Any history of intracranial implant including cochlear implant, implanted electrodes/stimulators, aneursym clips or coils, stents, bullet fragments; implanted cardiac pacemaker, defibrillator, vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects contraindicated by product labeling. 7. Neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, history of repetitive or severe head trauma, or with primary or secondary tumors in the CNS. 8. current pregnancy or breast feeding. The effects of TMS on pregnant and breastfeeding patients has not been systematically studied. 9. Infection or loss of integrity of skin over the forehead, where the device will be positioned. 10. Increased risk of seizure as indicated by: a) history (or family history) of seizure or epilepsy; b) history of stroke, head injury, or unexplained seizures; c) concurrent medication use such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower the seizure threshold; d) secondary conditions that may significantly alter electrolyte balance or lower seizure threshold; e) no quantifiable motor threshold such that TMS dosage cannot be accurately determined. 11. Known bee, insect, or arachnid allergy 12. Other medical contraindications to any of the study procedures | 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 Depression Postictal Delirium Electroconvulsive Therapy Adulthood (age > 17 years) Current clinical diagnosis of depressive episode (unipolar, bipolar, schizoaffective) Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements Known adverse or allergic reactions to acetaminophen or nimodipine Chronic use of acetaminophen, calcium-antagonists or NSAID's that cannot be interrupted for less than two days before the ECT-session Contraindications for magnetic resonance imaging (e.g. ferromagnetic implants, pacemakers, claustrophobia) | 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, Chronic Stroke chronic stroke (never experienced AOT) first-ever unilateral stroke due to ischemia provoking a clinically evident upper limb/hand deficit diagnosis verified by brain imaging (MRI) cognitive function sufficient to understand the experimental instructions Chedoke-McMaster stroke Assessment Scale score greater than 1 informed written consent to participate in the study bilateral impairment severe sensory deficits in the paretic upper limb cognitive impairment or behavioral dysfunction refusal or inability to provide informed consent and other current severe medical problems | 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): 16.0-50.0, Neonatal Encephalopathy Epilepsy Newborn Morbidity All pregnant women delivering at 36 weeks or later Premature deliveries | 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): 18.0-75.0, Epilepsies, Focal Diagnosis of treatment-resistant epilepsy of any syndrome, in which seizures are detectable in scalp EEG with two electrodes Between the ages of 18 Experiencing >20 seizures (with impaired awareness) per year according to seizure diary Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures) Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors) Inability to comply with the trial procedure, such as cognitive or behavioral problems Inability to give informed consent History or evidence of: Severe cardiac disease (including Pacemaker and ICD-unit), Myocardial infarction, angina pectoris or other ischaemic heart disease, Cardiac arrhythmia or Any other heart failure History or evidence of: Stroke, Transient ischaemic attack, Carotid or vertebral artery stenosis or dissection, Cerebral hemorrhage, Any other structural cerebral disease Use of following drugs: Chemotherapeutic drugs of any kind, Methotrexate, Anticoagulation treatment, Immunosuppressant treatment, Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine) Subjects under investigation or treatment of active cancer or cancer diagnosis within the past 5 years Subjects known with or suspected abuse of alcohol (defined as consumption of > 250g alcohol per week or abuse of any other neuro-active substances Subjects involved in therapies with medical devices that deliver electrical energy into the area around the implant | 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, Spinal Cord Injuries Adult individual 18 yr. of age or older. 2. Cognitively intact and capable of giving informed consent. 3. Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine 4. Patient and Caregiver agree to use Care Connect app or web version of VirTrial platform for virtual visits Prior history of: 1. Recent or ongoing infection, 2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease, 3. Neurodegenerative disorders, 4. Cancer, 5. Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening, 6. Chemical or ETOH dependency, 2. Having a contraindication to MRI scans 3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration 4. Participation in other interventional research studies. 5. Unwillingness to return for follow-up visits | 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 To be eligible for entry into the study, candidates must meet all the following Be enrolled in 11-N-0051 Epilepsy Surgery Able to give informed consent Age greater than or equal to 18 years and less than or equal to 65 years Candidates will be excluded if they: -Have any disability that would limit their ability to perform study tasks that examine memory function | 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): 18.0-90.0, Treatment Resistant Depression Diagnosis of major depressive disorder using mini-7 to derive RDC; DSM-IV Pretreatment HRSC score greater than or equal to 18 ECT indicated by physician evaluation Willing and capable of providing informed consent as determined by physician evaluation History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by mini-7; rapid cycling defined as greater than or equal to four episodes in past year History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation ECT in the past six months determined by physician evaluation and medical history Pregnancy as determined by urine pregnancy test and clinical interview | 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 Seizure Disorder All epilepsy patients admitted to Duke Hospital for surgical placement of depth electrodes age 18 and up are eligible | 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 Patients diagnosed as primary epilepsy either newly diagnosed or on AEDs Aged above 18 years old Males and females Patients diagnosed as secondary epilepsy (post stroke, trauma, tumor, encephalitis, etc) Patients diagnosed as epilepsy syndrome | 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): 21.0-60.0, TBI Cognitive Dysfunction Post 9/11 Veterans age 21-60; with history of mild-moderate TBI (including reported mechanism of head injury and alteration of consciousness) in the chronic, stable phase of recovery (>6 months from injury); with at least 1 self-reported cognitive symptom, --including difficulties with working memory; and interested in goal-setting and intensive training Severely apathetic/abulic, aphasic, or other reasons for being unable or unwilling to participate in training severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains) schizophrenia bipolar disorder history of other neurological disorders current medical illnesses that may alter mental status or disrupt participation in the study active psychotropic medication changes symptom magnification or malingering | 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): 18.0-100.0, Facial Pain Documented diagnosis of classic trigeminal neuralgia or persisten idiopathic facial pain Considered an appropriate candidate for surgical or stereotactic intervention - microvascular decompression or stereotactic radiosurgery ( includes factors such as overall health, chronic medication, comorbidities) and patient preference Between ages 18-100 Able to participate in 5 consecutive TMS treatments Has at least 3 weeks between pre-op visit and scheduled date of surgery Able to provide consent and complete online questionnaires on their own Multiple Sclerosis or trauma-related etiology of facial pain (i.e. secondary facial pain) contraindication to TMS, per device guidelines: Metallic implant in or near head Implanted stimulator on or near head recent suicidal ideation history of epilepsy, stroke, or unexplained seizure Need for urgent/emergent surgical decompression | 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, Epilepsy Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution Same dosage form and strength of generic substitution to original levetiracetam Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution Stable dose of generic levetiracetam after generic levetiracetam substitution Absence seizure with levetiracetam monotherapy Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution Poor compliance Death or loss of follow up Unavailable data for evaluation of outcomes | 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, Migraine Head Pain Diagnosis of migraine (episodic or chronic) according to the International Classification of headache Disorders (ICHD), 3rd version, criteria10. Being treated with Candesartan under the of the physician and according to local guidelines. Age >18 years. More than 4 days of headache per month in the preceding 3 months. More than 1 year of migraine evolution. Beginning of migraine before the age of 50. Ability to provide informed consent Previous failure of three or more preventive drugs in accordance with the definition provided below. Concomitant use of another preventive drug or use of it in less than 5-half lives of the drug. History of another active primary headache with a periodicity considered frequent according to the International Classification of Headache disorders, that is, more than 10 days per month at the time of screening or the basal period. Continuous or daily headache in the month prior to in the study. Pregnancy or breastfeeding. Any relevant cardiovascular conditions. Kidney diseases. Hyperkaliemia. Use of another concomitant preventive. Previous use of candesartan. Current use of another Angiotensin Conversing Enzime Inhibitor or Angiotensin-II receptor antagonist. Alcoholism or drug use. Concomitant treatment: The study will not interfere in the current practice, participants will receive the candesartan in the same manner and intensity if they were not enrolled in the study. Patients will be allowed to use their usual symptomatic treatment as usual. The number of days of symptomatic treatment and the number of use of triptans will be reflected. The concomitant drugs with potential use as a preventive according to National Clinical Practice guidelines (gabapentin, pregabalin, tricyclic antidepressants, duloxetine, valproic acid, phenytoin, lamotrigine, topiramate, botulinum toxin, anti-CGRP antibodies, beta-blockers, lisinopril) will not be permitted. Treatment failure shall be defined as insufficient efficacy at a sufficient dose and for an adequate duration or withdrawal due to adverse effects of a drug present in the national headache guidelines | 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, Refractory Epilepsy Inclusion/ - For a subject to be eligible for this study, he or she must meet ALL of the following 1. Subject is male or female between the ages of 18 to 70 years old. 2. Subject is considered an appropriate surgical candidate by the implanting Neurosurgeon. 3. Subject has had confirmed refractory epilepsy for a minimum of 2 years, with unilateral or bilateral temporal lobe involvement with no more than 2 known extratemporal foci. 4. In the opinion of the Investigator, subject has disabling seizures. 5. Subject has had at least one seizure recorded by EEG or video EEG or invasive monitoring within the past 3 years consistent with focal temporal lobe seizures (a normal interictal EEG is consistent with focal seizures) 6. Subject has not achieved effective results previously from at least 3 AEDs in single or combination. An AED may be counted as failed medication if subject has been on it for at least 3-months and is still refractory. 7. Subject failed to obtain an adequate intake of oral valproate of at least 1,000 mgs a day and/or to achieve serum level of at least 60 µg/mL or in the opinion of the Investigator is not a candidate for oral valproate (including subject preference) 8. Per medical history, for the 3 months before informed consent an average of six or more disabling focal seizures of temporal lobe onset, with or without secondary generalization, per month. 9. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver. 10. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements. 11. Subject agrees to maintain the diary for the duration of the study alone or with the assistance of a competent individual. Subjects must NOT meet any of the following to be eligible for enrollment: 1. Subject has any neurologic or medical disease that is likely to progress over the course of the study and/or would interfere with the study. 2. Subject has any coagulopathy, ventricular anatomic distortion, or previous brain resection. 3. Subject has history, within 12 months prior to consent, of repetitive seizures that cannot be counted with confidence by the subject or competent adult/caregiver. 4. Subject has history of psychogenic nonepileptic seizures or seizures secondary to illicit drug or alcohol use, neoplasia, active central nervous system infection, demyelinating disease, degenerative neurological disease, progressive CNS disease or metabolic illness. 5. Subject has had status epilepticus refractory to benzodiazepines and a second agent within one year prior to consent 6. Subject is currently taking neuroleptic medication for behavior control. 7. Subject has a clear brain anatomic structural related lesion which distorts the normal anatomy or interferes with CSF fluid flow. 8. Subject has required (in addition to low dose stable use of benzodiazepines as part of antiepileptic regimen), in the 3 months prior to consent, benzodiazepine use more than 5 times per month for rescue seizure control. One use is defined as taking up to 3 doses in a 24-hour period. 9. Subject is currently implanted with an activated DBS, or RNS device used for treatment of a neurologic or psychiatric condition. 10. Subject currently has VNS and the VNS stimulation parameters are not stable. Stable shall be defined such that the stimulation parameters have not been changed in the last 3 months or the patient/designee is able to report "magnet swipe" during the same time period. The Investigator believes that the continued stable parameters can be maintained through the Primary Evaluation Period. 11. Subject has had more than 10 seizures in one day or more than 200 seizures in one month within last year. 12. Subject has known allergy to citrate, citric acid, valproic acid, divalproex sodium, any components of CT-010, or Depacon®. 13. Subject has unstable depression being treated with more than 1 antidepressant 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 has had a suicide attempt within the previous five years. Also excluded are subjects with a history of prolonged postictal psychosis or psychosis or depression secondary to a discontinued AED. 14. In the opinion of the Investigator, the subject has a clinically significant or unstable medical condition (e.g., uncontrolled diabetes or CHF) or a progressive CNS disease that would limit the subject's entry into 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): 18.0-999.0, Alcohol Withdrawal Alcohol Withdrawal Delirium Patients will be eligible for randomization if he/she has met one of the following three conditions: 1. has required more than 10 mg of lorazepam within a one hour time period, 2. has required more than 30 mg of lorazepam within a four hour time period, or 3. requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms Patients will be excluded from the study if he/she: 1. has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission) 2. has severe hypotension requiring vasopressor support 3. is less than 18 years of age 4. is actively pregnant 5. has an allergy to either of the drugs being studied (phenobarbital or lorazepam) 6. is already intubated at the time of 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): 16.0-999.0, Epileptic Seizure Epilepsy Intractable Motor Seizure potential central lobe epilepsy on average 2 or more seizures per day or ongoing Epilepsia Partialis Continua (EPC) mentally and physically capable of giving informed consent minimally 3 anti-epileptic drugs been admitted without effect on seizure frequency (refractory epilepsy) coagulopathy, including use of anticoagulant or antiplatelet agents known allergy to the materials of the implant progressive neurological or systemic disease contra-indications to the presence of a chronically implanted device, such as the need for repeated MRI, or concurrent infections any brain lesion that would place the patient at an elevated risk for bleeding any progressive brain disease, e.g. Rasmussen's encephalitis or glioma presence of any active implanted metallic device, such as cardiac pace-maker, vagal nerve or deep brain stimulator, cochlear implants, spinal cord stimulator or metallic parts from non-medical origin presence of aneurysm clips seizure onset zone (SOZ) outside eloquent cortex | 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): 12.0-60.0, Epilepsy, Temporal Lobe Patients between 12 to 60 years old. 2. Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG. 3. At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline. 4. Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now. 5. Be able to complete seizure diary. 6. Agree to participate this study and sign informed consent Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus. 2. Patients with psychogenic non-epileptic seizures. 3. IQ < 70, or unable to complete the study. 4. Patients are pregnant or plan for it. 5. Patients with implanted electrical stimulation medical device. 6. Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases. 7. Patients with cerebral lesions which unsuitable for lead implantation | 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, Epilepsy; Seizure Patients with epilepsy undergoing a standard VEEG examination for clinical evaluation consenting to participate in the present study Patients not consenting to participate in the study | 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): 18.0-89.0, Epilepsy Seizures Diagnosis of epilepsy Diet arm participants who plan to newly initiate treatment with the Modified Atkins Diet (MAD) within the next 2 months as an adjunctive treatment for epilepsy Control arm participants who do not plan to initiate ketogenic dietary therapy in the next 6 months Diagnosed sleep disorders (obstructive sleep apnea, primary insomnia, idiopathic hypersomnia, narcolepsy type I or II, REM sleep behavior disorder) Previously attempted dietary therapy for epilepsy who were not successful or compliant Anticipated need to adjust anti-seizure medications within the next 3 months Already on a ketogenic diet at the beginning of the study Planning to pursue surgical treatment for epilepsy in the next 6 months Non-English speakers Standard modified Atkins diet (see below) At the discretion of the PI Live greater than 20 miles from the greater Madison area (in case there is a need to personally pick up the home sleep monitor at the participant's home) | 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 Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy 2. Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before 3. The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to the participant in the study 4. Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC 5. Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated Participants with known psychogenic non-epileptic seizures 2. The participant had already received perampanel in the past 3. Simultaneous participation in an interventional clinical study and/or taking an investigational drug | 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 Subdural Hematoma Adult patients (aged ≥18 years) Symptomatic aSDH needing operative treatment via craniotomy or craniectomy Informed consent Patients with infaust prognosis Asymptomatic patients with conservative treatment aSDH as a secondary diagnosis Concurrent enrollment in any other trial | 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): 65.0-999.0, Epilepsy Aging Disorder Aging Epilepsy; Seizure Age ≥ 65 years 2. Ability of patient/legal representative to understand the study and to give his/her non-opposition (at the investigator's discretion) 3. Epilepsy with refractory partial-onset seizures with or without secondary generalization confirmed or with primary generalized tonic-clonic (PGTC) seizures 4. At least one seizure in the last three months 5. Treatment for partial-onset seizures with ESL as a first line monotherapy or with an adjunctive therapy History of ESL treatment 2. History of status epilepticus, seizures occurring in cluster, pseudo-seizures 3. History of severe hepatic impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 times ULN, gamma-glutamyltranspeptidase (GGT) > 5 times ULN) 4. History of severe renal impairment (clearance CLCR <30ml/min) 5. History of hypersensitivity to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) 6. History of severe hyponatremia (< 120 mmol/L) 7. Second or third degree atrioventricular block 8. More than one other antiepileptic drug | 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, Recurrent Glioblastoma age 18 years or older 2. progressive GBM based on the RANO and whole brain MRI according to the consensus recommendations for a standardized brain tumor imaging protocol in clinical trials , not older than 4 weeks from the assessment 3. estimated survival≥ 3 months 4. supratentorial tumor location 5. focal disease in the vicinity of the previously known tumor or resection cavity, 6. KPS≥70 7. ability to comply with TTFields treatment 8. for diagnostic or therapeutic neurosurgery and subsequent best practice oncological therapy, 9. tumor characteristics indicating significant expected benefit from feasible craniectomy or SR-surgery combined with TTFields i.e. (a) focal tumor and (b) most superficial border of tumor or resection cavity closer than 2 cm from brain surface 10. use of validated anticonception for fertile female participants in concordance with guidelines provided by the danish health and medicines authority, 11. signed written consent form pregnancy or nursing (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy) 2. infra-tentorial tumor 3. implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmia 4. uncontrollable symptomatic epilepsy refractory to standard medication 5. contraindications for skullremodeling surgery, e.g.bleeding diathesis or severe infection 6. significant co-morbidities, i.e. (a)significant liver function impairment (alt >210 u/l for men and > 135 u/l for women or total bilirubin >25umol/l), (b)significant renal impairment (serum creatinine > 1.7 mg/dl= 150 umol/l), (c)coagulopathy (inr> 1.8 or aptt > 57s), (d) thrombocytopenia (platelet count < 100 x 103/μl =100 x 109/l), (e) neutropenia (anc< 1.5 x 103/μl =1.5 x 109/l), (f) anemia ( hb < 10 g/l= 6.0 mmol/l) 7. severe cognitive impairment 8. active participation in another therapeutic interventional clinical trial | 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): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug | 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, Idiopathic Generalized Epilepsy Partial Onset Seizures Generalised Tonic-Clonic Seizures Diagnosis of epilepsy 2. History of POS with or without SG or PGTCS associated with IGE 3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months 4. Previously treated with 1 or 2 AEDs as monotherapy 5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency Episode(s) of status epilepticus within the past 6 months before Screening 2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies) 3. Previous or current use of perampanel Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the does not exceed 7 calendar days 4. Hypersensitivity to perampanel or any of the excipients | 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, Partial Seizures Prescribe perampanel according to the approved indication 2. Participants with focal seizures with or without secondary generalization 3. Participants with seizure frequency data available at the baseline visit 4. Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel 5. The decision to prescribe perampanel is made by the physician before and independently of his/her decision to the participant in the study 6. Treatment with perampanel is not yet started before baseline Participants contraindicated for perampanel use (according to SmPC) 2. Participants with moderate to severe renal impairment 3. Participants with severe hepatic impairment 4. Pregnant or lactating women 5. Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation | 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): 3.0-12.0, Absence Epilepsy Ketogenic Dieting Epilepsy, Absence Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically Normal intellect or mild disability EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation Daily reported absence seizures Generalized convulsions allowed Previous treatment with any anticonvulsant drug Previous use of a ketogenic dietary therapy for epilepsy or any other condition Glut1 deficiency syndrome Metabolic disorder known that would preclude dietary therapy Dietary restrictions for which a high fat, low carbohydrate diet would be precluded Prior history of epilepsy (febrile seizures allowed) Unwilling to consent to study procedures or return for visits | 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, Hyperhomocysteinemia, Thrombotic, Cbs-Related Ischemic Stroke Epilepsy The patients with adult-onset epileptic seizures and diagnosed ischemic stroke in 3 years period Pediatric patients with epileptic seizures | 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): 40.0-85.0, Glaucoma Open-Angle Primary Cataract General 1. Male and female patients, from 40 to 85 years of age, inclusive. 2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively. 3. Patient is able to understand the information sheet and give informed consent. for the study eye: 4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification. 5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma). 6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment). 7. An optic nerve appearance characteristic of glaucoma with either: 1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or 2. (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled). 8. Shaffer grade ≥2 in all four quadrants on gonioscopy. 9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes Diagnosis of Primary angle closure glaucoma. 2. Any diabetic retinopathy. 3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye. 4. Congenital or developmental glaucoma. 5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure). 6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery. 7. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%). 8. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout). 9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention). 10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye. 11. Previous vitreo-retinal surgery. 12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae). 13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle. 14. Degenerative visual disorders such as wet age-related macular degeneration. 15. Clinically significant ocular pathology other than cataract and glaucoma. 16. Clinically significant ocular inflammation or infection within 1 month prior to screening. 17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork. 18. Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits. 19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye). 20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives. 21. Unwilling or unable to give informed consent/unwilling to accept randomisation. 22. Unwilling or unable to return for scheduled protocol visits. 23. Any not met | 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): 11.0-25.0, Ataxia, Cerebellar Adolescents and young adults who aged 11-25 years Childhood ataxia Intelligence Quotient > 80 Presence of contraindication to tDCS (history of epilepsy, migraine, severe brain trauma; presence of metal in the brain/skull or implanted neurostimulator, cardiac pacemaker; state of pregnancy) Intake of or withdrawal from some drugs potentially changing the seizure threshold Presence of comorbidity with an important medical conditions Severe sensorial, motor and/or behavioural problems that could interfere with the use of GRAIL/VR technology | 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): 1.0-18.0, Epilepsy in Children Pharmaco-Resistant Epilepsy Study participant and/or legal representative is willing and able to give informed consent/assent for participation in the study Study participant and/or legal representative is willing and able to comply with all study requirements, in the opinion of the Investigator Study participant is between the ages of 12 and 21, inclusive, at the Screening Visit Study participant resides at home (alone or with family) Study participant has a confirmed diagnosis of epilepsy (epilepsy groups only; not applicable to sibling controls) Study participant has continued unprovoked seizures despite trials of ≥2 appropriate antiepileptic drugs at therapeutic doses (pharmaco resistant epilepsy group only; not applicable to pharmaco sensitive epilepsy group or sibling controls) Study participant has monogenic epilepsy Study participant has a neurodegenerative disease, mitochondrial disease, metabolic disease, active central nervous system disease, active autoimmune disease, or active inflammatory bowel disease Study participant is on, or has been on within 30 days prior to the Screening Visit, a ketogenic diet, low glycemic index diet, or modified Atkins diet therapy Study participant has had surgery within 3 months of the Screening Visit Study participant is a resident in a group or hospital setting Study participant requires the use of a g-tube or formula feeding Study participant has had antibiotic therapy within 60 days prior to the Screening Visit Study participant has participated in the study of an investigational product within 3 months prior to the Screening Visit (or within 5 half lives of the investigational product, whichever is longer) or is currently participating in a study of an investigational product | 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): 1.0-18.0, Epilepsy Study participant and/or legal representative must be willing and able to give informed consent/assent for participation in the study Study participant and/or legal representative must be willing and able to comply with all study requirements, in the opinion of the Investigator(s) Study participant is <18 years of age at the Screening Visit Study participant has refractory epilepsy Study participant has a known cardiac disorder including arrhythmias or hypertension Study participant has carnitine deficiency (primary), carnitine palmitoyltransferase I or II deficiency, or carnitine translocase deficiency Study participant has beta-oxidation defects medium-chain acyl dehydrogenase deficiency, long-chain acyl dehydrogenase deficiency, short-chain acyl dehydrogenase deficiency, long-chain 3-hydroxyacyl-coenzyme A deficiency, or medium-chain 3-hydroxyacyl-CoA deficiency Study participant has a pyruvate carboxylase deficiency Study participant has porphyria Study participant is unable to maintain adequate nutrition Study participant has a surgically remediable cause for refractory epilepsy Study participant has a suspected mitochondrial disorder or has been diagnosed with a disorder in which a high-fat diet is contraindicated Study participant has previously received a ketogenic diet or modified Atkins diet | 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, Right-sided Colon Cancer Right-sided Colon Adenoma for track 1 and 2a Male and female patients above 18 years of age with either: right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 1. Right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 2a ASA I,II or III The caecum must be reached by the endoscope. for retrospective controls (track 2b): Male and female patients above 18 years of age who were operated for colon adenoma ≥2cm in diameter in the right hemicolon in 2018 at Department of Surgery, Zealand University Hospital. They will be matched 2:1 with the patients included in track 2a (cases) based on age and gender and pathology of the tumor for track 1 and track 2a 1. Patients with previous allergic reaction to fosfomycin and/or metronidazole 2. Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion. 3. Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1) 4. Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection. 5. Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) 6. Patients with a history of inflammatory bowel disease (IBD) 7. Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®) 8. Patients under current treatment with Fenemal (Phenobarbital) 9. Patients who previously have received a fecal transplantation 10. Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor. 11. Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men. 12. Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally, impaired etc) 13. Patients with an American Society of Anaesthesiologists physical status 14. Classification (ASAscore) of IV. 15. Patients unable to be sedated 16. Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) 17. Fertile women who do not use safe contraception during the study period 18. Following contraceptive methods are acceptable when used consistently and in accordance, with both the product label and the instructions of the physician are Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system with a documented failure rate < 1% per year Male partner sterilization (vasectomy with documented azoospermia) prior to female patient ́s entry into the study, and this male is the sole partner for that patient Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository) for retrospective controls (track 2b) | 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): 5.0-18.0, Benign Epilepsy With Centrotemporal Spikes Language Problems Learning Disorders A diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis will be based on a history of a focal motor seizure (affecting the face or causing hypersalivation) or a history of a seizure out of sleep AND an EEG with unilateral or bilateral centrotemporal spike waves English-speaking History of prematurity < 35 weeks gestational age History of serious neurologic problems (i.e. history of other seizure disorder other than simple febrile seizure, head trauma with prolonged loss of consciousness, cerebrovascular accident or neuro-inflammatory disease) Focal deficits on neurologic exam History of abnormal MRI (with clear gray or white matter abnormality) | 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, Epilepsy Focal Cortical Dysplasia Tuberous Sclerosis Hemimegalencephaly Polymicrogyria Rasmussen Encephalitis Sturge-Weber Syndrome Gliosis Stroke Tumor, Brain Participants with epilepsy who candidates for surgical treatment as established by a multidisciplinary committee specialized in epilepsy Participants undergoing resective surgery for epilepsy of dysplastic (examples: focal cortical dysplasia, tuberous sclerosis, hemimegalencephaly, polymicrogyria) or non-dysplastic etiology (examples: developmental tumors, gliosis, stroke, Rasmussen encephalitis, Sturge-Weber syndrome) Lesion of interest located in a difficult to access region, such as paralimbic structures, insula, depth-of-sulci or inter-hemispheric | 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): 18.0-64.0, Epilepsy patient of the Texas Comprehensive Epilepsy Program at UTHealth-McGovern Medical School diagnosis of epilepsy be able to provide consent in English complete surveys independently be able to sync Fitbit data currently using a wearable physical activity tracker prior to enrollment pregnant or planning to become pregnant during the study duration planning to undergo epilepsy surgery during the study duration | 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, Epilepsy Patients with clinically confirmed epilepsy in adult patients Non-symptomatic epilepsy Normal CT or MRI brain, and Education level of primary school at least to respond to the scales correctly were included Psycho-neurological illnesses History of alcoholism or drug abuse, or Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs) | 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, Neurological Diseases or Conditions Stroke, Acute Seizure Disorder for the extended study Adult patients New onset of neurological symptoms Independent in daily activities (modified Rankin Scale ≤ 2) Stroke or epilepsy/seizure Pre-existing neurodegenerative disease Diagnosed with cerebral neoplasm Pre-existing expected life expectancy < 3 months Suspected non-organic (functional) disorder | 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, Epilepsy Patients seen in an institution in the public sector of Mexico that belong to the Epilepsy Priority Program Informed consent and assent of participation in the project Patients with any form of epilepsy Patients seen by a Pediatric Neurologist or Neurologist Patients who decide at any time not to participate Incomplete data of their disease Non-epileptic seizures Inadequate information from the patient, family member or informant | 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): 45.0-999.0, Cognitive Decline Men and women over the age of 45 MMSE score < 30 MMSE score ≥ 10 Patient is able to collaborate No other cognitive comorbidity No seizure event Advanced stage of cognitive decline (MMSE < 10) Any verbal or non-verbal form of objection from patient or form patient's family member or significant other Presence of several cognitive comorbidity Damage to integrity of scalp and/or skull Skin irritation in the facial and forehead area Significant hearing impairments History of drug abuse | 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): 2.0-999.0, Refractory Epilepsy Development Delay Age ≥2 years Disease history of at least 24 months from date of first seizure Medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression Medical history of onset of seizures in early childhood (≤ 8 years) Failure of adequate trials of two tolerated and appropriately chosen and used Anti-Epileptic Drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom Ongoing refractory epilepsy MRI and EEG data are available for the participant Participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified Normal cognitive development Any acute symptomatic seizures in participants with underlying developmental delay Any progressive intellectual and neurological deterioration conditions | 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 WITH Participants will subjects with epilepsy, based on clinical history, imaging studies and ictal and/or interictal EEG interpreted by a clinical epileptologist. Seizures may be either symptomatic or idiopathic, primary generalized or focal-onset, and traumatic or non-traumatic in etiology. Subjects must have self-reported cognitive dysfunction. Subjects must meet the following Age > or = 18 years old IQ > or = 70, estimated by the Wechsler Test of Adult Reading (WTAR) Capacity to provide informed consent Ability to live independently and complete activities of daily living Stable seizure frequency at the time of enrollment, such that the subject's treating physician does not believe a change in anticonvulsant regimen to be warranted during the trial (the anticonvulsant drugs should remain unchanged during the 16 weeks of participation unless absolutely required clinically due an unanticipated change in seizure frequency or severity) Fluency in English Psychogenic, non-epileptic spells Diagnosis of dementia (i.e., Alzheimer's disease) Other progressive neurologic illness (i.e., malignant brain tumor). A benign, stable neoplasm with no plans for resection will not be cause for exclusion Alcohol or illicit drug abuse within the past year, as this may affect cognition by other mechanisms. This information may be obtained by self-report, from the referring physician or by medical record. Subjects will also undergo urine drug testing at the baseline visit. Chronic, stable use of marijuana will not be cause for exclusion. In cases of intermittent, recreational use, it will be required that subjects refrain from marijuana for 2 weeks prior to testing. Cannabidiol use will be permitted Generalized tonic-clonic or other generalized motor seizure(s) within 48 hours or focal-onset seizures with impaired awareness within 24 hours of neuropsychological testing. This restriction will avoid testing during a post-ictal state. This timing is conservative, based on practice as well as prior studies of post-ictal cognitive function demonstrating return to baseline within one day (Dodrill and Ojemann, 2007; Helmstaedter, Elger, & Lendt, 1994) Prior status epilepticus in the past year Neurosurgery within the past 6 months, as there may be recovery in cognition post-operatively Current pregnancy or pregnancy planned during the trial Breastfeeding Concurrent treatment with a monoamine oxidase inhibitor (MAOI; e.g., selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue), or use of an MAOI within 14 days of beginning the trial (due to the risk of hypertensive crisis) | 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): 16.0-60.0, Analgesia age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy pregnancy or breast feeding neurological deficits or neuropathy opioid addict local skin infections, bleeding diathesis, and coagulopathy | 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): 40.0-80.0, Frontotemporal Dementia FTD Participants Diagnosis of probable Frontotemporal dementia (bvFTD) Mini Mental State Examination (MMSE) > 18 FTLD-specific Clinical Dementia Rating (FTLD-CDR) total score of ≤1 On stable medications related to cognition or behavior for >30 days such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines Age from 40 to 80 years Minimum of completed 8th grade education No history of intellectual disability Current or past history of any significant neurodegenerative disorder of the central nervous system other than FTD e.g. Alzheimer's disease, Lewy body dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, normal pressure hydrocephalus, Huntington's disease, any condition directly or indirectly caused by Transmissible Spongiform Encephalopathy (TSE), Creutzfeldt-Jakob Disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or new variant Creutzfeldt-Jakob Disease (nvCJD) Current or past history of stroke (cortical stroke), intracranial brain lesions, previous neurosurgery or head trauma that resulted in residual neurologic impairment Non-cortical disease such as confluence white matter changes (including lacunar infarcts < 1cm) and asymptomatic, subacute, cerebellar infarcts may be included upon review of a medically responsible neurologist Past or current history of major depression, bipolar disorder, psychotic disorders, or any other major psychiatric condition will be evaluated by the study MD Current history of poorly controlled migraines including chronic medication for migraine prevention History of seizures with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator History of fainting spells of unknown or undetermined etiology that might constitute seizures Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) Metal implants in the head (except dental), pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD Contraindication for undergoing MRI or receiving TMS or tACS | 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, Intellectual Disabilities Nutritional Intellectual Disability Mild intellectual disability and overweight Moderate intellectual disability and overweight Metabolic diseases Hypertension Diabetes | 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): 65.0-999.0, Cognitive Dysfunction Mini-Mental State Examination (MMSE):20~28 Clinical Dementia Rating (CDR): 0.5~1 CDR>1 | 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, Facial Nerve Paresis Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6 History of epilepsy or seizures Individuals with metal orthopedic implants in the mouth (e.g. plates or screws) Individuals suffering from fibromyalgia Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST) | 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): 6.0-12.0, Hearing Impairment Sensorineural Hearing Loss, Bilateral children ages 6 to 12 years English as the primary home language positive for bilateral symmetrical mild to moderately-severe sensorineural hearing loss currently using hearing aids that were dispensed at least 18 months prior to enrollment of the study negative for major cognitive handicap or developmental delay that would prevent or restrict participation, as determined by the PI or designee negative for learning disability, for example attention-deficit/hyperactivity disorder, as determined by the PI or designee negative for serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee informed consent of parent/guardian assent of participating child if aged 11 years and over standard MRI as set by the Cincinnati Children's Hospital Medical Center department of Radiology | 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): 18.0-75.0, Ischemic Stroke Be between 18 and 75 years old Victim of a first ischemic stroke in superficial Sylvian territory with at least frontal damage Cerebral ischemic lesion demonstrated by MRI Stroke older than one year Presence of a motor hemi-syndrome with at least one involvement of the upper limb Stable neurological deficit in motor function of the limb greater than two months apart before enrolling the patient in the study Woman of childbearing potential with a negative blood pregnancy test before the biopsy and using a reliable method of contraception during the study Patient capable of discernment and of giving informed consent himself Absence of other serious pathologies or comorbidities Brain lesions or a history of stroke or brain hemorrhage Signs of peripheral neurological damage, such as radicular or trunk involvement History of spinal cord problems History of neurosurgical intervention in the brain surgical intervention contraindications Anticoagulation, if it cannot be interrupted one week before and one week after each of the 2 brain surgeries Coagulation disorders Treatment of botulinum toxin during the last 3 months before inclusion Seizures or anti-epileptic treatment Global cognitive disorders, such as degenerative or vascular dementia | 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, Epilepsy Epileptic Encephalopathy Refractory Epilepsy adult (age>18 yrs) and pediatric (age<18yrs) outpatients with established diagnosis of epilepsy | 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, Partial Epilepsy Patients currently enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021. 2. Patient who is currently pregnant and enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021 may enter the EAP program. 3. Written informed consent signed by the patient or legal guardian prior to entering the EAP in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021 | 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 meeting the definition of epilepsy according to the new definition issued by ILAE in 2014 not using antidepressants acquiring informed consents patients with severe psychiatric symptoms progressive brain diseases malignant tumors severe cognitive declines | 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 Subject is 18-75 years old Semiology of seizures compatible with temporal lobe involvement Paraclinical findings supporting temporal seizure focus. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT) Uncontrolled epileptic seizures Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant Subject is willing and able to provide written informed consent Subject is able to complete all study-required procedures, assessments and follow-up Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease Subject receives frequent (more than 2 days per week) treatment with drugs of the following types: 1. antiplatelets 2. anticoagulants 3. chemotherapeutics 4. non-steroid anti-inflammatory drugs (NSAID) Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement Subject has an active deep brain stimulation device Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant Subject has a cochlear implant(s) | 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, Focal Epilepsy Completed the DA07976 Study 2. In the opinion of the investigator, if the subject were to be removed from study and associated therapy, subject would have worsening/increase in 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. 3. Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium). 4. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver. 5. 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. 6. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements. 7. Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing. 8. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual. 9. 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 per SOE Subject has any significant neurologic disease other than epilepsy. 2. Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year 3. Subject is currently taking oral valproic acid or sodium divalproex. 4. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon. 5. Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study. 6. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%. 7. Subject has current diagnosis of cancer requiring treatment. 8. Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason. 9. Subject has known HIV infection or known or suspected prion disease. 10. Subject has known allergies to drugs or excipients. 11. Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study 12. 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 that in the opinion of the Investigator would put the subject at risk as a participant in 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, Epilepsy Surgery Drug Resistant Epilepsy All patients with focal epilepsy who are refractory to medical treatment Patients accept surgical maneuver Epileptic patients responding to medical treatment Patients refusing surgical intervention Patients unfit for brain surgery Multi focal or generalized 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): 18.0-999.0, Epilepsy Over 18 years of age An unprovoked seizure within the last year or a diagnosis of epilepsy according to the current International League Against Epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years) Expected survival less than two years Inability to give informed consent | 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, Aneurysmal Subarachnoid Hemorrhage Aneurysmal SAH confirmed with vascular imaging Aneurysm treated with endovascular or microsurgical intervention Hunt-Hess ≤ 4 Modified Fisher Grade I-IV Glasgow Coma Scale (GCS) ≥ 7 following External Ventricular Drain (EVD) placement if indicated First dose of drug can be administered within 24 hours of symptom onset Functional independence prior to SAH, Modified Rankin Scale (mRS) ≤ 1 Informed consent obtained by patient or legal authorized representative (LAR) Previous hypersensitivity to or treatment with deferoxamine Presence of giant aneurysm (>25 mm in size) Known severe iron deficiency anemia, Hemoglobin (Hgb) g/dl ≤ 7 or transfusion dependent Irreversibly impaired brainstem function Abnormal renal function, Serum Creatinine> 2 mg/dL Pre-existing severe disability, mRS ≥ 2 Coagulopathy, including use of anti-platelet or anticoagulant drugs Known severe hearing loss Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or on home oxygen (O2) Taking iron supplements containing > 325 mg of ferrous iron | 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): 4.0-18.0, Rolandic Epilepsy Rolandic Epilepsy, Benign Centrotemporal Epilepsy Centrotemporal; EEG Spikes, Epilepsy of Childhood Epilepsy; Seizure Epilepsy Ages 4-18 years 2. Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist 3. Has EEG with sleep activated centrotemporal spikes 4. Has had at least 1 focal motor or generalized seizure Has abnormal brain MRI 2. Has other unrelated neurological disease 3. Unable to have an MRI/MEG 1. Claustrophobic 2. History of frequent vomiting 3. Permanent metal in body, braces 4. Over MRI weight limit: 350lbs | 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, Severe Covid-19 Proven SARS-CoV2 infection Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation) Evidence of coagulopathy (indicated by D-dimer > 10 mg/L) Evidence of systemic inflammation (CRP > 100 mg/L , ferritin > 500 ng/mL) • Participation in another study with investigational drug within the 30 days preceding and during the present study Previous enrolment into the current study Extra corporeal membrane oxygenation (ECMO) | 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 ≥ 18 years of age diagnosed with refractory focal epilepsy have a seizure frequency of ≥ 1 per month only one seizure type, or in case of multiple seizure types only seizures that correspond to one probable onset zone (e.g. focal and focal to bilateral tonic-clonic seizures) have daytime seizures (exclusively or both daytime and night-time seizures) those with at least one seizure that has been recorded during a video-EEG, or those who undergo a presurgical evaluation during the study period including a video-EEG recording with tapering of antiseizure medication mentally competent and with no learning disabilities able to keep a seizure diary including time and date (as judged by the treating physician) have an Android-operating smartphone use their phone with at least 5 distinct smartphone apps at a minimum of 5 days a week not fulfilling the above mentioned | 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, Gangliosidoses GM1 Gangliosidosis Morquio B Disease Sialidosis Galactosialidosis Gm2-Gangliosidosis, Variant B1 Tay-Sachs Disease Sandhoff Disease GM2 Activator Deficiency Biochemically and/or genetically affirmed diagnosis of a gangliosidosis The patient or respectively the parents or the caregiver (for children or older underage patients) have given written informed consent The diagnosis of a gangliosidosis has not biochemically or genetically confirmed A written informed consent of the patient or parents/acaregiver does not exist | 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): 60.0-90.0, Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Cognitive Impairment Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the study Have a study partner Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study Poor venous access Contraindication to PET or MRI imaging | 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, Epilepsy Patients who are 18 years of age or older, who signed an informed consent form, and teenagers over 16 years of age who assent, with their parents signing an informed consent form, and Epilepsy syndrome: idiopathic generalized epilepsy (n=15), patients at increased risk for SUDEP, i.e. have more than 1 nocturnal tonic clonic seizures (TCS) per month (n=15), refractory focal epilepsy with a presurgical evaluation at UZ Leuven (n=30) Minimum one seizure per month Patient is able and motivated to handle the Sensor-Dot and Plug 'n Patch system independently, to fill out the Helpilepsy app on a daily basis and to wear the Sensor-Dot and Plug 'n Patch system for a full year 24/24-7/7; fallback option for patients for whom wearing the device during the day is too obtrusive: measurement only during the evening and nighttime Inability to provide written informed consent or assent Known allergy to electrodes and patches Implanted device, such as a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation 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): 3.0-35.0, Interictal FDG-PET Hypometabolism Patterns (a) Pharmacoresistant Epilepsy may be defined by International League Against Epilepsy (ILAE）as failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom (judged by two epileptologists); (b) conventional MRI negative or nonspecific abnormalities; and (c) detailed information of long-term video-EEG, FDG-PET, high resolution MRI (HR-MRI) and neuropsychological assessment were acquired, (d) focal epilepsy defined by combining clinical, electrophysical and neuroimaging (a) generalized or multifocal epilepsy or the patient's electroclinical features were inconsistent with pharmacoresistant epilepsy; (b) idiopathic focal epilepsy; and (c) unsatisfactory imaging quality. - | 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, Automatic Seizure Detection Patients with drug-resistant epilepsy candidate to the surgery underwent to non-invasive EEG monitoring Patients with at least one recorded seizure during the EEG monitoring Patients with drug-resistant epilepsy candidate to the surgery underwent to non-invasive EEG monitoring Patients with no recorded seizure during the EEG monitoring | 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, Dexmedetomidine Postoperative Delirium Patients undergoing selective frontotemporal tumor resection Age ≥18 years Obtain written informed consent Refusal to provide written informed consent Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20) Allergic to the study drug History of psychotropic drugs Pregnant or lactating women History of traumatic brain injury or neurosurgery Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block Severe hepatic or renal dysfunction | 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, The Aim the Study is to Collect and Analyze Data on Patients With Acute Ischemic Stroke During Intravenous Thrombolytic Therapy With Alteplase To be included in the study, patients must meet the following 1. Patients of any sex and age with a confirmed diagnosis of ischemic stroke (AII); 2. Carrying out the patient with intravenous thrombolytic therapy with the drug alteplase (Revelisa®). - | 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 Adult patient (≥ 18 years old) Patient with drug-resistant focal epilepsy, undergoing SEEG exploration Healthy subject, devoid of central neurological pathology, major ((≥ 18 years) Patient or healthy subject capable of giving informed consent for the study MEG "incompatible" healthy patients or volunteers Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible Patients or healthy volunteers who cannot stand standing still for a few minutes Pregnant or breastfeeding women Adults under guardianship or under legal protection People deprived of their liberty People who have not signed the 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): 8.0-12.0, Autism Spectrum Disorder Age ranges from 8 to 12 years Mild to moderate autistic features according Gilliam autism rating scale: (scores from 60 to 110) Mild to moderate mental retardation (IQ of 35-70) Can understand and follow simple instructions Significant visual or auditory defects History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder) History of surgical interference or fractures of the upper limbs in the last 12 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): 0.0-999.0, Epilepsy Surgery--Complications (i) medically refractory epilepsy defined by the International League Against Epilepsyc; (ii) epilepsy surgery performed by a single neurosurgeon, Dr. H.Z.; (iii) surgical procedure performed via craniotomy Patients with neuromodulation therapy were excluded 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): 18.0-999.0, Ischemic Stroke Subarachnoid Hemorrhage, Aneurysmal Sepsis TBI (Traumatic Brain Injury) ICH - Intracerebral Hemorrhage HIE - Hypoxic - Ischemic Encephalopathy Aneurysmal subarachnoid hemorrhage (aSAH), Traumatic brain injury (TBI), Acute ischemic stroke (AIS), Intracerebral hemorrhage (ICH), Ischemic hypoxic encephalopathy (HIE), sepsis-associated encephalopathy (SAE) who need to reduce the core temperature to normal Age < 18 years old Pregnancy The temporal window was limited and the image could not be obtained Patients with bradycardia induced by common carotid artery compression and intolerant of THRT Patients with severe carotid artery disease Uncorrected severe coagulation disorders and active bleeding Patients without informed consent Patients who had been treated with hypothermia before | 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, Aggression Adults aged 18-64 years Diagnosis of a developmental disability History of one or more incidents of aggression in the last month Consent to participate in the trial by the individual or their Substitute Decision Maker History of epilepsy or seizures History of acquired brain injury Having metal in the brain/skull, e.g. splinters, fragments or clips Having a cochlear implant Having an implanted neuro-stimulator (e.g. direct brain stimulation, epidural/subdural stimulation, vagal nerve stimulation) History of brain surgery of procedure History of severe adverse reaction to tDCS Having a cardiac pacemaker or intracardiac lines Current alcohol or drug misuse Having a sensitive scalp | 0 |
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