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

Date Added
February 8th, 2022
PRO Number
Pro00118031
Researcher
Ezequiel Gleichgerrcht

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

A Long-term Safety Study to Assess the Potential for Chronic Liver Injury in Participants Treated with Epidiolex® Cannabidiol Oral Solution

Date Added
December 15th, 2021
PRO Number
Pro00111927
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This is a study designed to assess whether there will be injury to the liver in participants who are already being treated Epidiolex or who are about to begin treatment with Epidiolex
Participants ages 18 and above on existing Epidiolex treatment for FDA-approved indications and participants with no previous experience of Epidiolex and who are about to be prescribed Epidiolex for an FDA-approved indication will be recruited from multiple sites in the US.
This study will include a screening period of up to 21 (┬▒ 7) days to assess participant eligibility. A physical exam, blood/serum laboratory tests, laboratory
scoring and transient elastography ( a type of imaging test ) by FibroScan® to assess liver fibrosis will be performed in all participants entering into the study and repeated annually thereafter for up to 5 years.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843 792-1115
bulgarino@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

A 57-WEEK, MULTICENTER, ACTIVE-TREATMENT, OPEN-LABEL EXTENSION TRIAL OF CVL-865 AS ADJUNCTIVE THERAPY IN ADULTS WITH DRUG-RESISTANT FOCAL ONSET SEIZURES

Date Added
February 9th, 2021
PRO Number
Pro00106750
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

This 57-week, active-treatment, open-label (all participants will receive study drug throughout the study) extension trial ( enrolls participants of a previous clinical trial into another study) in which all participants gets the study drug is designed to assess the safety and tolerability of CVL-865 as adjunctive treatment (another treatment used together with the primary treatment) in subjects with drug-resistant focal onset seizures. This trial is open to subjects who completed treatment with the investigational medicinal product (IMP) in the double-blind (neither the participant or researchers know what study drug they are receiving) Phase 2 Trial CVL-865-SZ-001 and who, in the opinion of the investigator, could potentially benefit from treatment with CVL-865. There are 17 visits for a duration of 57 active-treatment weeks. The visits are approximately one month apart.

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

Localizing Epileptic Networks using 3T MRI

Date Added
September 29th, 2020
PRO Number
Pro00102615
Researcher
Leonardo Bonilha

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

Clinical and laboratory studies to determine the causes of neurological disease in adults and children

Date Added
September 15th, 2020
PRO Number
Pro00102718
Researcher
Catherine Ziats

List of Studies

Keywords
Alzheimers, Autism, Dementia, Epilepsy, Mental Health, Multiple Sclerosis, Parkinsons
Summary

Neurological diseases are the leading cause of disability worldwide and a major contributor to health problems in children and adults. As the majority of these conditions result in lifelong disabilities, the implications for the family and for society is significant.

A significant number of adult and childhood neurological diseases have a genetic component and are caused by changes in our DNA and/or RNA leading to functional changes in the central nervous system. However, for many patients afflicted with these disorders, traditional genetic testing does not identify a clear genetic cause. The goal of this study will be to use newer genetic techniques to evaluate patients and families with neurological disorders to better understand the genetic basis of the disease.

Institution
Self Regional
Recruitment Contact
Catherine Ziats
8642507944
cziats@ggc.org

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults with Drug-Resistant Focal Onset Seizures (REALIZE Trial)

Date Added
March 10th, 2020
PRO Number
Pro00096604
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

The purpose of this study is to find out if a drug called CVL-865 is safe and effective in the treatment for focal onset epilepsy. The study has an 8-week screening period, followed by a treatment period where adults 18 - 75 years of age that qualify for treatment will be randomly assigned to 3 different dose levels of the study drug. This is followed by a 4-week safety follow up period. The study will last approximately 25 weeks with approximately 7 research related clinic appointments. Participants that successfully complete the treatment period will also have the option of participating in a separate open-label extension study and all participants will be taking the study drug.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
843-792-1115
Bulgarino@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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