Realistic measurements of tDCS-modulated activity and electric fields in the human brain in vivo Save

Date Added
September 19th, 2017
PRO Number
Pro00069308
Researcher
Pratik Chhatbar

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Keywords
Brain, Epilepsy, Nervous System
Summary

In this study, we will use electrodes implanted inside the skull and over the scalp to study the effect of non-invasive brain stimulation method called transcranial direct current stimulation (tDCS). We will record changes in electric brain potentials and brain activity as a result of tDCS at both inside skull at scalp level. We will use this information to interpret how tDCS leads to changes inside the brain leading to changes the brain activity. This study will help us develop interventions that involve use of tDCS in a variety of disease conditions like stroke, depression, addiction, etc.

Institution
MUSC
Recruitment Contact
Fay Davis
843-792-0883
davisfa@musc.edu

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation Study With an Open-Label Phase to Examine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-935 as an Adjunctive Therapy in Subjects With Developmental and/or Epileptic Encephalopathies Save

Date Added
June 27th, 2017
PRO Number
Pro00066787
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult subjects with developmental and/or epileptic encephalopathies. This is a phase 2 multi-center, randomized, double-blind, placebo-controlled, dose-escalation study with an short open-label phase. The goal is to do some dose ranging and assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Additionally, subjects will have screening for a genetic marker of risk for antiepileptic-drug hypersensitivity syndrome.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

NSF 1649865 EAGER: Next-Generation Neural Data Analysis (NGNDA) Platform: Massive Parallel Analysis of Multi-Modal Brain Networks Save

Date Added
April 18th, 2017
PRO Number
Pro00064530
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

This project proposes to develop a system to analyze electroencephalography (EEG) and magnetic resonance imaging (MRI) data from clinical studies of patients with epileptic seizures. This will be called the Next-Generative Neural Data Analysis (NGNDA) platform. This system will use new high-performance computing tools and algorithms to analyze high-dimensional brain data from EEG and MRI. The plan is to create tools for analyzing these big data clinical studies that clinicians can use to improve the care of patients with epilepsy.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

Transcranial magnetic stimulation as a treatment for seizures Save

Date Added
March 21st, 2017
PRO Number
Pro00063419
Researcher
Leonardo Bonilha

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Keywords
Brain, Epilepsy
Summary

A seizure is a common sign or symptom characterized by abnormal electrical activity in the brain that affects about 10% of individuals in the population at some point in their lives. Although most are self-limited and transient, seizures sometimes fail to respond to medications and may even progress despite administration of medications. When these seizures are characterized by spread to both sides of the brain (become generalized), aggressive management with sedating medications is warranted. However, if seizures remain confined to one side of the brain (remain focal), the risks associated with high doses of sedating medications often outweighs the potential benefits of stopping the seizure. This has led to a search for other therapies that can more effectively target and control focal seizures without causing significant sedation, damage to other organs, or medication interactions. Transcranial magnetic stimulation (TMS) is one such therapy that has shown promise in case series and case reports, although no clinical controlled trial has yet been published to validate its efficacy in patients with severe seizures. In addition, TMS has been shown to be safe for use in epilepsy and other disorders.

We aim to evaluate the efficacy of TMS in patients with severe seizures that are not controlled with medications.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
22845
choudhur@musc.edu

An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects with Partial Onset Seizures Save

Date Added
December 13th, 2016
PRO Number
Pro00061843
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

This research study is designed to evaluate the safety of YKP3089 and to
further evaluate how YKP3089 and other anti-epileptic drugs (AEDs) affect each other in the body when given together. The study will also evaluate long term safety of YKP3089 as adjunctive therapy in partial onset seizures.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes Save

Date Added
December 1st, 2015
PRO Number
Pro00049665
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

The purpose of this study is to find out if the study medication, GWP42003-P (also known as cannabidiol, CBD), can help control seizures and is safe in children and adults with Dravet or Lennox-Gastaut syndrome (LGS). GWP42003-P is an investigational medicinal product.

The active study medicine is cannabidiol (CBD), known as GWP42003-P. It is extracted from cannabis plants (marijuana) under highly controlled conditions to ensure the product is always the same.

Participants must have previously participated in the core studies and participation is expected to last 36 months.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

High Performance Seizure Monitoring and Alert System ? Phase IIB Save

Date Added
July 21st, 2015
PRO Number
Pro00045896
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

The purpose of this project is to develop a highly accurate, reliable, and user-friendly electroencephalogram (EEG) recording and seizure monitoring and alert system (CereScope™) for use during times where patients require close EEG monitoring to detect seizures.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures with a Seizure Detection and Warning System in Epilepsy Patients Save

Date Added
March 24th, 2015
IRB Number
20848
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

The goal of this study is to determine the effectiveness of the Companion™ device to detect GTC seizures and alert someone to the seizure.

Institution
MUSC
Recruitment Contact
Becky Hamrick
(843) 792-3855
hamrickr@musc.edu

A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome Save

Date Added
March 24th, 2015
PRO Number
Pro00038643
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

The purpose of this study is to find out if the study medication, GWP42003-P (also known as cannabidiol, CBD), can help control seizures and is safe in children and young adults with Dravet syndrome. We will be comparing the GWP42003-P medicine with a dummy medicine (placebo) that looks, smells, and tastes just like GWP42003-P, but does not have any active ingredient.

GWP42003-P is an investigational product. This means it has not been approved by the Food & Drug Administration for the treatment of epileptic seizures in people with Dravet syndrome.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
843-792-3855
hamrickr@musc.edu

Human Epilepsy Project Save

Date Added
June 18th, 2013
PRO Number
Pro00024605
Researcher
Jonathan Halford

Silhouette
Keywords
Central Nervous System, Epilepsy
Summary

Epilepsy affects more than 1% of the population. About 1/3 of people with epilepsy will be unable to control their seizures successfully. Among the 2/3 that do achieve seizure control, many will have tried multiple medications over many years, with varying side effects. The goal of this study is to use easily available information such as common diagnostic tests (MRI, EEG, blood samples) to learn how to identify early-on which people are likely to have side effects from treatments, as well as difficult-to-control epilepsy. By gaining this knowledge, we hope to get people the appropriate treatments more promptly, and reduce the number of side effects they experience on their way to seizure control.

Institution
MUSC
Recruitment Contact
Rebecca Hamrick
792 3855
hamrickr@musc.edu

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