Ultra-long-term EEG monitoring in PwID
Research type
Research Study
Full title
Acceptability and impact of ultra-long-term subcutaneous EEG monitoring in people with epilepsy and intellectual disability.
IRAS ID
343424
Contact name
Rohit Shankar
Contact email
Sponsor organisation
University of Plymouth
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Many people with intellectual disabilities (PwID) have seizures. Electroencephalography (EEG), which measures the brain’s electrical activity, is a key method of diagnosing and assessing seizures but be difficult and uncomfortable for PwID. UNEEG medical has developed a very small device (‘SubQ’) that can be put under the skin on a person’s head to track their brain activity without staying in the hospital. It has been implanted for 15 months successfully in people with seizures but not in PwID.
The aim of this project is to use learnings from previous co-production work to test how well the device can detect seizures in people with moderate to profound ID and to assess its safety and impact on quality of life and behaviour. We will also look into carer’s experiences using the system and its potential usefulness and cost impact. Having an accurate means of identifying seizures is particularly important for people with moderate to profound ID because they cannot tell us about their experiences. This means that seizures are more likely to be missed or attributed to behavioural issues.
Healthcare professionals will identify patients to be invited to participate in the study; as they lack the capacity to provide informed consent, their legal representative will make the decision based on best interests. The 10 patients who participate in the study will have the UNEEG SubQ device implanted under the skin on their scalp. We will collect ongoing EEG data from the device and compare it with seizure diaries. We will also examine behaviour and quality of life using surveys before implantation as well as immediately, 3-months, and 6-months after. Carers and healthcare professionals will be invited to focus groups to share their experiences with the technology.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0206
Date of REC Opinion
18 Jul 2024
REC opinion
Unfavourable Opinion