Real World Testing and Cost-effectiveness of SubQ EEG (REAL-ASE)
Research type
Research Study
Full title
Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
IRAS ID
324630
Contact name
Mark Richardson
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 3 months, 30 days
Research summary
Epilepsy is common, has high morbidity, mortality, and costs. Epileptic seizures are the key symptom. In clinical practice, a participant-reported seizure diary is the ubiquitous approach to documenting seizures, but evidence suggests diaries are unreliable.
The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electrical brain wave (encephalogram, EEG) device called UNEEG™ SubQ, (i) is more accurate than a seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the NHS.
This prospective cohort study will enrol 33 adult participants with epilepsy across four centres in England and Wales.
Participants will undergo a brief structured entry interview to obtain information about their epilepsy and expectations of the device. Participants will be implanted with EEG™ SubQ under local anaesthesia, and collect EEG data for 6 months. Estimates of times of occurrence of seizures recorded with the EEG™ SubQ will be collected as well as the participant’s electronic seizure diary reports of times of occurrence of seizures. Treating clinicians will be sent a structured report about seizures documented with the device every week and will be able to access the full EEG data at any time. Treating clinicians will report to participants about seizures documented with the device every month. Participants will complete brief validated questionnaires at baseline, after 2 months using the device and after 6 months. Participants will undergo a structured exit interview to obtain information about changes in their epilepsy and experiences with the device.
The study will not alter therapy, and treating clinicians are free to manage the participant’s epilepsy as usual, making use of information from the device if they wish.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0419
Date of REC Opinion
14 Jul 2023
REC opinion
Further Information Favourable Opinion