SUBER
Research type
Research Study
Full title
Subcutaneous EEG: forecasting of epileptic seizures through investigation of long-term dynamics of seizure occurrences, stress, sleep and other factors
IRAS ID
252686
Contact name
Mark Richardson
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of the project is to develop a method to forecast epileptic seizures, through investigating the long-term dynamics of seizure occurrences, stress, sleep and other factors. Patients regard the development of a seizure forecasting method as extremely important, as a step towards reducing the frequent harms caused by seizures, which include serious injury and death.
The target population is 10 adults (18 to 75 years of age) with a diagnosis of treatment-resistant epilepsy. There will be no change to usual care as a result of taking part.
Participants will be recruited from the Epilepsy Clinic, who have at least 20 seizures per year, and whose seizure onset recorded from scalp EEG is localized to a brain region accessible by subcutaneous EEG electrodes. A subcutaneous EEG device will be implanted under the skin on the scalp, behind the ear, using local anaesthesia. The participant will be trained in collecting data from it.
Non-invasive wrist or arm-worn sensors (similar to familiar wearables such as FitBit) will be used to acquire signals related to heart activity and rate, movements, muscle activity, electrodermal activity, and body temperature during long-term recording of subcutaneous EEG (up to one year). The subcutaneous device will be removed at the end of the study.
Digital data from the devices will be analysed using computational methods including artificial intelligence. The association will be investigated between non-invasive measurable variables related to stress and sleep, semi-invasive subcutaneous EEG phenomena, and the occurrence of seizures. The predictive value of change in non-invasive variables and semi-invasive subcutaneous EEG phenomena for the occurrence of seizures will be assessed. Anonymised data will be shared with research collaborators in Europe, USA and Australia.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0354
Date of REC Opinion
6 Mar 2019
REC opinion
Favourable Opinion