Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
Tuberous Sclerosis ComplexEpilepsyThis phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome (SWS)...
Sturge Weber SyndromeSturge Weber Syndrome (SWS) is a rare disease that affects the patient's brain and causes benign (non-cancerous) tumors to grow in the brain. One of the symptoms of SWS is epilepsy. People with epilepsy have seizures. Some patients may also have eye problems and a red mark on their facial skin. This study is being done to find out if the study drug, everolimus, is safe and has helpful effects in patients with SWS who have seizures and are not responding to their current anti-epileptic medication. The study drug, everolimus (Afinitor®), is supplied by Novartis Pharmaceuticals Corporation.
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
EpilepsyThe purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.
Study of Phenobarbital Inhibition of Catamenial Epilepsy
EpilepsyThe purpose of this study is to test the effectiveness of low-dose Phenobarbital on the treatment of catamenial epilepsy. We propose that since the catamenial seizures are associated with the reduction in levels of GABA-enhancing allopregnanolone, short-term replacement with the GABAR-enhancing agent Phenobarbital will reduce the incidence of catamenial seizures.
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Migraine With AuraAssess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of migraine with aura The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop or interrupt the spreading cortical brain activity that causes or contributes to the migraine headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately 30 seconds apart, may stop the aura and prevent the subsequent headache.
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare...
EpilepsyTo evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
Transcranial Stimulation During Sleep to Improve Cognition in Epilepsy
EpilepsyAim 1: Determine whether sleep enhances learning across a range of cognitive domains in healthy subjects. Aim 2: Determine whether low-frequency transcranial stimulation (TCS) delivered during slow wave sleep (SWS), compared to sham stimulation, enhances learning outcomes as indexed by a complete neuropsychological battery of tests in epilepsy patients and healthy control subjects. Aim 3: Determine whether low-frequency TCS delivered during SWS, compared to sham stimulation, enhances sleep architecture associated with enhanced memory consolidation (ie. increased coherence of slow wave activity and increased frequency of sleep spindles). Aim 4. Determine whether low-frequency TCS during sleep results in a more distributed memory representation, as suggested by increased hippocampal-perirhinal connectivity on fMRI in human subjects. Aim 5. Determine whether the frequency of interictal activity during sleep in epilepsy subjects is associated with the degree of cognitive benefit conferred by SWS. These studies will provide critical pilot data on whether non-invasive brain stimulation protocols previously tested in healthy subjects can be extended to epilepsy patients for potentially therapeutic cognitive benefits.
Balance and Anti-Epileptic Drugs
EpilepsyPatients with epilepsy exercise less than the general population. A barrier to exercise may be the effect of antiepileptic drugs on balance and reaction time. This proposal endeavors to study the effect of two common antiepileptic drugs (levetiracetam and lamotrigine) on balance and reaction time using a Wii balance board and reaction time test. This will be tested at descending doses in an epilepsy monitoring unit. Drug levels will be monitored, as well as center of pressure, and reaction time.
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
HyponatremiaMetabolic Bone DiseaseThe study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia. The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured. The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.
A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents...
EpilepsyA pediatric drug study to determine the long-term safety and tolerability in children and adolescents (4-17 years in age) taking the drug (elsicarbazepine acetate)