Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
May 28th, 2024
PRO Number
Pro00135072
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. Participation in this study is expected to last approximately 18 to 20 weeks, or about 4 months.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Impact of capturing ictal events with ultra-long-term ambulatory EEG monitoring with REMI.

Date Added
June 27th, 2023
PRO Number
Pro00129426
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This study is being done to understand whether a different type of electroencephalography (EEG) monitoring that permits longer monitoring is able to capture more seizures than regular EEG monitoring, and whether this new type of monitoring will improve clinical care. This type of EEG monitoring (REMI) is currently cleared by the United States Government Food and Drug Administration (or FDA) for use in hospitals but not yet cleared to be used at home.
Eligible subjects who have EEG monitoring scheduled with either a 3-day EEG monitoring performed at home or with a 3-day EEG monitoring schedule at the Medical University of South Carolina (MUSC). Subjects are in the study for approximately 4 weeks and will need to come to the study center for one or two visits. They will be asked to wear 4 of Epitel's REMI Sensors on their head, in addition to the regular EEG electrodes, for two 2-week REMI EEG monitoring periods. A 2nd visit (clinic visit) at MUSC may be needed if the recording is at MUSC, in order to start the second REMI EEG monitoring session.
At the end of the study, three independent epileptologists will review the REMI EEG recordings and compile a report of any findings. They will then provide this report to the subject's neurologist who will assess the value of the additional EEG information, and save the report within the MUSC medical record.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Assessment of Potential Biomarkers of Seizure Susceptibility Using Novel NextSense EEG Earbuds

Date Added
February 8th, 2022
PRO Number
Pro00118031
Researcher
Ekrem Kutluay

List of Studies


Keywords
Epilepsy
Summary

The purpose of this study is to understand whether there may be certain characteristics or patterns that might predict seizure events in patients undergoing EEG monitoring and at home. Researchers will also be assessing the comfort and usability of a new device called NextSense EEG earbud device at the same time as routine inpatient epilepsy monitoring unit (EMU) admissions, as well as device use in the home environment. In order to enroll in the at-home extension, the participant must be enrolled in the inpatient EMU admission portion of the study. Participants will be asked to assess their mood, sleep quality, and the comfort and usability of the device during their inpatient admission at regular intervals. If participating in the at-home extension, these same assessment questionnaires, in addition to a seizure diary, will be completed by participants at regular intervals.

Institution
MUSC
Recruitment Contact
Lindsey Weissman
843-792-2330
weissmal@musc.edu

Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Date Added
October 19th, 2021
PRO Number
Pro00113242
Researcher
Jonathan Halford

List of Studies

Keywords
Epilepsy
Summary

This study aims to improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). We will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. We will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.

Institution
MUSC
Recruitment Contact
to be decided
843-789-7428
jonathan.halford@va.gov

Localizing Epileptic Networks using 3T MRI

Date Added
September 29th, 2020
PRO Number
Pro00102615
Researcher
Alexandra Parashos

List of Studies

Keywords
Epilepsy
Summary

The purpose of this research study is to study the capabilities of new methods for studying the brain using Magnetic Resonance Imaging (MRI). MRI already provides detailed images of brain anatomy, but newer methods including new MRI techniques and magnetic resonance spectroscopy expand this capability. These new MRI methods will not require any invasive procedures. If successful, these new methods will expand the information, which can be obtained from MRI studies of the brain in patients with epilepsy.

Institution
MUSC
Recruitment Contact
Lindsey Weissman
843-792-2330
weissmal@musc.edu

eACT (epilepsy: Adherence in children and technology)

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

List of Studies


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
Shannon Williams
843-792-2201
wilshann@musc.edu



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