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
347327
Contact name
Rohit Shanker
Contact email
Sponsor organisation
University of Plymouth
ISRCTN Number
ISRCTN43074815
Duration of Study in the UK
1 years, 1 months, 28 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 can 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 mild to moderate ID and to assess its safety and impact on quality of life and behaviour. We will also look into carer and clinican experiences using the system and its potential usefulness and cost impact. Having an accurate means of identifying seizures is particularly important for people with mild to moderate ID because they cannot always tell us about their experiences in a meaningful manner. This means that seizures are more likely to be missed or attributed to behavioural issues.
Healthcare professionals will identify eligible patients to be invited to participate in the study. These patients will be diagnosed with mild to moderate ID, but will have the capacity to consent to take part in the study. 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 any behaviour issues and quality of life using surveys before implantation as well as immediately, 3-months, and 6-months after. The patients, their 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/0300
Date of REC Opinion
17 Oct 2024
REC opinion
Favourable Opinion