NEAT v1.0
Research type
Research Study
Full title
Neuromodulation of Epileptogenicity by Autonomic Training (NEAT)
IRAS ID
317342
Contact name
David Carmichael
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Epilepsy affects an estimated 70 million people around the world and is one of the most common neurological disorders in children as well as adults. In as many as 1/3 of patients, seizures are poorly controlled with medication. Recent drug development has provided potential solutions, however, rates of drug-resistant epilepsy remain relatively unchanged in the last 30 years. Urgent new treatments are needed.
Galvanic Skin Response (GSR) modulation is one potential alternative treatment that has been shown to reduce seizure rate, though the acute mechanistic effect of GSR is yet to be elucidated. Further establishing the feasibility of GSR modulation as a tool to combat epilepsy is of great importance and is the focus of the NEAT project.
We will interrogate the acute effects of GSR modulation on the brain dynamics of patients with Generalised Genetic Epilepsy (GGE) using ultra-high field 7 Tesla functional Magnetic Resonance Imaging (fMRI). We will also investigate if abnormal epileptiform intracranial EEG patterns observable between seizures can be reduced with GSR modulation or direct neurofeedback of the abnormal activity.
The cohort will comprise of 20 patients with Genetic Generalised Epilepsy (GGE) and 5 patients with focal epilepsy. There will be two parts to this study. The first will be Guy's and St Thomas' Hopsital NHS Foundation trust where there will be GSR modulation training and GSR-fMRI. The second site will be King's College Hospital where GSR modulation will occur during icEEG. The study will last 11 months.
Medical outcomes will be monitored for a further 2 years for a comparison between any findings from the scalp EEG, icEEG and MRI data to the ongoing health of the patient.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0036
Date of REC Opinion
24 Mar 2023
REC opinion
Further Information Favourable Opinion