PRX-00023 Therapy in Localization-Related Epilepsy
EpilepsyEpilepsy2 moreBackground: - The brain chemical serotonin helps nerve cells communicate. Previous research suggests that serotonin activity may be lower in brain areas where seizures start, and that increasing activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers are interested in determining whether the experimental medication PRX-00023, which increases the activity of serotonin receptors, can reduce seizure frequency in people whose seizures are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied in people with epilepsy and has not previously been given to people taking antiseizure medication at the same time. Objectives: - To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures that start from only one part of the brain. Eligibility: - Individuals between 18 and 65 years of age who have frequent epileptic seizures even after trying at least two different standard anti-seizure medications (either at the same time or one after the other). Design: The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period. Individuals who choose to participate in additional studies may be an inpatient during some of these visits. Participants will be screened with a medical history and physical examination, blood and urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and MRI scans Participants will have a 6-week observation and evaluation period before starting the study medication. Participants who have at least four seizures during this period will be eligible for the treatment portion of the study. All participants will receive either PRX-00023 or a placebo pill twice daily for 12 weeks, and will have regular clinic visits with blood samples and imaging studies. After the 12-week period, participants will have a 2- to 3-week washout period without any study medication. Participants will then have another study medication period, and will receive the opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase. Participants will continue to have regular clinic visits with blood samples, ECG, EEG and neuropsychologicalstudies. One month after the end of the second study medication phase, participants will have a followup evaluation with a physical examination, blood tests, ECG, EEG, mood and neuropsychological tests. Outcome measures: The primary outcome measure for drug efficacy will be: Mean difference in seizure frequency comparing the active and placebo periods. Secondary outcome measures for efficacy will be: Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than placebo Hamilton Depression and Anxiety Rating scales Performance on mood and neuropsychological testing scales
A Multicenter Study of Hippocampal Electrical Stimulation (HS, in Mesial Temporal Lobe Epilepsy...
Temporal Lobe EpilepsyThe primary goal is to determine whether hippocampal electrical stimulation (HS) is safe and more effective than simply implanting an electrode in the hippocampus without electrical stimulation (HI), in patients with mesial temporal lobe epilepsy (MTLE). This will be assessed by the rate of complex partial seizures per person-month over 6 months of follow-up in HS vs. HI. There are two treatment arms: 1) Hippocampal Electrode Implantation with Stimulation (HS). 2) Hippocampal Electrode Implantation without stimulation (HI). The investigators expect to demonstrate that HS is safe and superior to HI in controlling seizures in patients with MTLE.
Epilepsy Surgery and Cognitive Outcome
EpilepsyTemporal LobeThis study will give important information about long term consequences of temporal lobe epilepsy surgery on cognition (memory, language, concentration etc), psychiatric function and quality of life.
SEEG Guided RF-TC v.s. ATL for mTLE With HS
EpilepsyTemporal LobeMesial temporal lobe epilepsy (mTLE) is the most classical subtype of temporal lobe epilepsy, which is the indication of surgical intervention after evaluation. Until now, anterior temporal lobectomy (ATL) is still the recommended treatment for mTLE. However, evidences are accumulated including post ATL tetartanopia and memory deterioration and new minimized invasive treatments are introduced. Stereotactic EEG (SEEG) guided radio-frequency thermocoagulation (RF-TC) is one of the option with lower seizure freedom but with higher neurological function reservation. This study is aiming at comparison of the efficacy and safety between SEEG guided RF-TC and classical ATL in the treatment of mTLE.
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
EpilepsyTemporal LobeThe overall goal of this study is to open up the promising treatment of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective against seizures in patients with surface neocortical foci, to a much larger population of patients with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are not currently considered good rTMS candidates. The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients with deep seizure foci by targeting its usage to accessible cortical partner regions. In this study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic stimulation protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
CBT Versus Selective Serotonin Reuptake Inhibitor For Treatment Of Depression In Temporal Lobe Epilepsy...
DepressionEpilepsy1 moreThe aim of the study is to compare the effect of group-cognitive-behavioral therapy (CBT)versus treatment as usual with the selective serotonin reuptake inhibitor sertraline, in patients with diagnosis of temporal lobe epilepsy (TLE) and depressive disorder.
Low Frequency Electrical Stimulation of the Fornix in Intractable Mesial Temporal Lobe Epilepsy...
Mesial Temporal Lobe EpilepsyThe primary aim of the current proposal is to evaluate safety and tolerability, in terms of neuropsychological effects of low frequency electrical stimulation of the fornix (LFSF) in participants with medically-intractable Mesial Temporal Lobe Epilepsy. Secondary aims include evaluation of psychiatric changes, seizure frequency, and quality of life during LFSF.
Early Surgical Intervention to Treat Epilepsy
EpilepsyEpilepsy2 moreThe purpose of this trial is to compare the effectiveness of early surgical intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
EpilepsyThis research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy
Major DepressionTemporal Lobe EpilepsyThis is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.