Ultra-long-term EEG Monitoring in PwID

University of Plymouth

Status: Active, not recruiting

Conditions: Epilepsy; Intellectual Disability, Mild to Moderate

Treatments: Device: A minimally-invasive EEG monitoring device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07385157

24NEU030

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

9 participants in 1 patient group

Cohort in people with intellectual disability and epilepsy

Description:

The target population of the study will include adult patients who are clinically diagnosed with mild to moderate intellectual disability and epilepsy who are recommended for EEG monitoring by their healthcare professional, their family members or carers, and the clinician responsible for their care.

Treatment:

Device: A minimally-invasive EEG monitoring device