eACT (epilepsy: Adherence in children and technology) Save

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies

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Keywords
Children's Health, Epilepsy, Pediatrics
Summary

The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.

Institution
MUSC
Recruitment Contact
Millie Griffin
843-792-4653
grifm@musc.edu

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy Save

Date Added
March 26th, 2019
PRO Number
Pro00085211
Researcher
Ekrem Kutluay

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

This study is to evaluate how safe the study drug XEN1101 is for patients with focal epilepsy when it is taken with the patients standard epileptic medications.

This investigational drug has been tested in healthy volunteers but this is the first time it will be tested in participants with focal-onset epilepsy. The study will last about 24 weeks and participants will need to visit the research clinic at least 10 times during the study. Visits will be approximately every 2 weeks, after the first two weekly visits folllowing the start of study treatment.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
Bulgarino@musc.edu

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerablity of TAK-935 as an Adjunctive Therapy in Pediatric Patients with Developmental and/or Epileptic Encephalopathies Save

Date Added
January 22nd, 2019
PRO Number
Pro00083332
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

The primary objective of this study is to investigate the effect on the frequency of all seizures in pediatric patients with developmental and/or epileptic encephalopathies treated with TAK-935 as adjunctive therapy compared to placebo, as well as evaluate the safety and tolerability of the study drug.

Study TAK-935-2002 includes pediatric patients (aged 2- 17 years) with Dravet syndrome experiencing convulsive seizures and and Lennox Gastaut syndrome experiencing drop seizures. The study cosists of 2 main periods: a 4-6 week screeing/baseline period followed by a 14 week treatment period. The treatment period consists of a 2 week titration period followed by a 12 week maintenance period. There will be approximately 6 clinic visits and 2 phone visits over 10 months.

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

Testing of ZETO EEG Recording Headset in a VA Community Based Outpatient Clinic Save

Date Added
August 21st, 2018
PRO Number
Pro00080373
Researcher
Jonathan Halford

List of Studies


Profiles_link
Keywords
Epilepsy
Summary

The study PI and ZETO staff will train a nurse at the Charleston VA to acquire EEGs using the ZETO dry electrode EEG system at a Community Based Outpatient Clinic (CBOC) in South Carolina. The location of the CBOC will probably be in Beaufort, SC, where a previous similar study was performed. This ZETO device is easy to use and can be set up in 5-10 minutes because it is a headset which is placed on the head without skin or hair preparation. A total of 20 Veterans who are scheduled to be seen for primary care appointments at a VA CBOC will be recruited. Each EEG recording will take about 30 minutes to complete (including set-up time). EEG setup time and patient comfort measures will be acquired. EEG signal will be analyzed for signal quality with assistance from an investigator at the School of Computing at Clemson University. Three neurologist co-investigators will also assist in analysis of the EEG recordings.

Institution
MUSC
Recruitment Contact
Elizabeth Aprile
843-789-7428
elizabeth.aprile@va.gov

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

List of Studies


Profiles_link
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

List of Studies

Silhouette
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

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

List of Studies


Profiles_link
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

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

List of Studies


Profiles_link
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

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