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