Neuro-Metabolic Dynamics in Epilepsy (NeuMeDE)
Research type
Research Study
Full title
Neuro-Metabolic Dynamics in Epilepsy (NeuMeDE): a pilot study
IRAS ID
345076
Contact name
Carolyn Read
Contact email
Sponsor organisation
University of Cambridge
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Vagus nerve stimulation (VNS) is a clinical standard of care in the UK to help people with epilepsy to reduce the frequency and severity of seizures. On the other hand, VNS has shown pre-clinical evidence in modulating glucose metabolism. Yet, the intricate connection between metabolic changes and epilepsy is often overlooked. For example, glucose fluctuations can trigger immediate hyperexcitability in cerebral regions causing seizures, highlighting the importance of stable metabolic control for individuals with epilepsy. In this pilot study, we want to understand the significance of this relationship and evaluate the feasibility of the experimental protocol for a future larger study, while identifying potential limitations and areas for refinement.
We will recruit 6 patients who will be implanted a VNS on the left vagus nerve following routine standard practice at King's College Hospital. Patients will receive the clinical pre-defined regime of stimulation for 6-months.
At least 1 month before the surgical schedule, on Visit 2 (consent visit), patients will receive:
• Implantation of a CE-marked continuous glucose monitoring (CGM) sensor (Freestyle, Abbott)
• Wearable activity watches to monitor activity and heart rate (e.g. Fitbit or personal tracker)
• Seizure diaries to be completed for the duration of the study.From visit 2, patients will conduct a standardised breakfast tolerance test (patient's own breakfast adapted to meet certain macronutrient composition) at least twice a week. Following the end of the trial (6-months following surgery / 7-months following enrolment into the trial), patients will stop wearing the CGM and wearable sensors, and will continue to be managed by their clinical team as per their individual clinical requirements.
The primary objective is to assess the experimental protocol and refine it for a larger cohort of patients. The secondary objective is to investigate challenges in combining and analyzing data collected from wearable devices and CGM sensors.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
25/NW/0016
Date of REC Opinion
31 Jan 2025
REC opinion
Further Information Favourable Opinion