NCT07385157Active, not recruiting
Ultra-long-term EEG Monitoring in PwID
Acceptability and Impact of Ultra-long-term Subcutaneous EEG Monitoring in People With Epilepsy and Intellectual Disability
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 9 (actual)
- First submitted
- 5 Jan 2026
- Start date
- 12 Oct 2024
- Primary completion date
- 12 Nov 2025
- Lead sponsor
- University of Plymouth
- Diseases
- Epilepsy
- NCT number
- NCT07385157
What you commit to
- Study type: Observational
- Participants enrolled: 9
- From 12 Oct 2024 to the primary completion date, 12 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patients:
- Adults over 18 years old
- Clinical diagnosis of epilepsy, considered pharmacoresistant
- Clinical diagnosis of mild to moderate ID based on the Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) and the International Statistical Classfication of Diseases and Related Health Problems (11th ed; ICD-11; World Health Organisation, 2022).Patient has the capacity to consent to take part in the study, and does so
- Able to tolerate the dummy device (device worn for at least 40% of a 1-2 week test period)
- Family member / carer:
- Family member/carer is willing to keep a routine seizure diary for the course of the study
- Retrospective seizure diary data available for the proceeding last 6 months
- According to family member, carer, or clinical record, the participant is having at least monthly 'episodes of interest' (it may be unclear whether these are epileptic or behavioural episodes)
- Agree to participate to the study, and support study activities and comply to these
- Healthcare professional:
- PwID recommended by their epileptologist for long-term EEG monitoring
- Agree to participate to the study, and support study activities and comply to these
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cornwall Partnership NHS Foundation Trust Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.