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Ultra-long-term EEG Monitoring in PwID
Sponsor: University of Plymouth
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. The project 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 patients who participate in the study will have the UNEEG SubQ device implanted under the skin on their scalp. Ongoing EEG data from the device will be collected and be compared with seizure diaries. The project 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.
Official title: Acceptability and Impact of Ultra-long-term Subcutaneous EEG Monitoring in People With Epilepsy and Intellectual Disability
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
9
Start Date
2024-10-12
Completion Date
2026-03-31
Last Updated
2026-02-03
Healthy Volunteers
No
Interventions
A minimally-invasive EEG monitoring device
The minimally-invasive EEG monitoring device (UNEEG Medical's 24/7 EEG SubQ solution) has been CE marked and will be used only in line with its intended use, which includes the population to be investigated in this study. The 2-channel 24/7 EEG SubQ solution is intended for measuring and recording electrical activity of the brain (EEG) through electrodes implanted subcutaneously in the tissue between the skull and the skin. Intended for participants where single location, continuous, ultra-long-term (more than two weeks) EEG recordings are indicated to aid in monitoring and diagnosis of diseases or conditions that alter the EEG. The intended users of the product are males and females, age 18 and above.
Locations (1)
Cornwall Partnership NHS Foundation Trust
Truro, United Kingdom