A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Exploring the Efficacy, Safety, and Tolerability of Natalizumab (BG00002) as Adjunctive Therapy in Adult Subjects With Drug-Resistant Focal Epilepsy Save

Date Added
February 13th, 2018
PRO Number
Pro00072354
Researcher
Jonathan Halford

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Keywords
Epilepsy
Summary

This in an exploratory study and the information obtained may lead to new findings regarding the treatment of seizures in adults with drug-resistant focal epilepsy. This study will explore the effectiveness, safety, and of a medication called natalizumab.

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

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

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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

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

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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

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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

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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

Measurement of Automated EEG Artifact Removal Performance Using Evoked Potentials Save

Date Added
April 16th, 2013
PRO Number
Pro00023968
Researcher
Jonathan Halford

Silhouette
Keywords
Epilepsy
Summary

EEG is the most common neurophysiology procedure. Unfortunately, EEG is plagued with the problem of artifacts. Artifacts are contaminant signals which come from other sources than the brain. These other sources are electrical potentials from eye movement, electromyogram (EMG) signals from muscles of the scalp, 60 Hz noise from the electrical power system, signals caused by patient movement, and noise from problems with individual EEG electrodes. The purpose of this study is to create EEG recordings from normal subjects that can be used to measure how well automatic EEG artifact removal software works. EEG recordings will be made from subjects during two states: (1) while subjects are at rest and (2) while subjects are being given somatosensory, visual, and auditory stimuli. The stimuli that will be used will be standard clinical somatosensory evoked potential stimuli using electrical shocks to the left wrist, flashing lights for a visual stimulus, and audio click sounds throughout headphones for the auditory stimuli. The averaged evoked potentials will be studied before and after automatic EEG artifact removal software is applied and comparied between the resting state and the stimulated state.

Institution
MUSC
Recruitment Contact
Kimberly Schnabel
843-792-3855
schnabel@musc.edu

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