Ultra-long-term EEG Monitoring in PwID

NCT07385157 | Active Not Recruiting

• 1 other identifier: 24NEU030
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intellectual Disability, Mild to Moderate; Epilepsy

Keywords

Epilepsy; Intellectual Disability; Persons with Mental Disabilities; Electroencephalography; Seizures; Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (3)

• Device acceptability

  The acceptability of the 24/7 SubQ device will be assessed using qualitative data about family members' and carers' perceptions of the patients' experiences with the device. The data will be collected from semi-structured focus groups.

  At 6 months post-implantation of the device

• Device adherence

  The adherence to use of UNEEG SubQ device will be assessed using participants' percentage wear time with 24/7 EEG SubQ.

  Across 6 months post-implantation of the device

• Device usability

  The usability of the UNEEG SubQ device will be measured using the average score at 6 months (before explantation) on the System Usability Scale (SUS). The SUS is a 5-point Likert scale 10 items, from strongly disagree (score = 1) to strongly agree (score = 5) \[1\].

  At 6 months post-implantation of the device

Secondary Outcomes (12)

• Device safety

  From implantation to explantation of the device

• Seizure detection accuracy

  Across 6 months post-implantation of the device

• Patients' quality of life

  At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation

• Patient behaviour

  At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation

• Satisfaction with the device in daily activities

  At 6 months post-implantation of the device

Study Arms (1)

Cohort in people with intellectual disability and epilepsy

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.

Device: A minimally-invasive EEG monitoring device

Interventions

A minimally-invasive EEG monitoring device 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.

Cohort in people with intellectual disability and epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. Involvement of a participants' family member and/or established carer will be mandatory for the study participation, to safeguard the participants' safety, rights, and well-being throughout the study. A primary carer (family member or professional, depending on the case) for the participant will be involved in the study and answer the questionnaires directed to the carer, participate in feedback consultation with the investigator, handle the device, keep a seizure diary and participate in focus groups to provide research data on behalf of the participant and their own experience.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Plymouth: lead
• Newcastle University: collaborator
• UNEEG Medical A/S: collaborator

Study Sites (1)

Cornwall Partnership NHS Foundation Trust

Truro, TR4 9LD, United Kingdom

Location

Related Publications (3)

• [3] Farmer C, Aman MG. Aberrant Behavior Checklist. Encyclopedia of Autism Spectrum Disorders Springer New York; 2020;1-8.

  BACKGROUND

• [2] Health of Nation Outcome Scales (HoNOS). Royal College of Psychiatrists. 2023. Available from: https://www.rcpsych.ac.uk/improving-care/ccqi/health-ofnation-outcome-scales [accessed May 10, 2024]

  BACKGROUND

• [1] Brooke J. SUS: a quick and dirty usability scale. ResearchGate. 1995. Nov, [2021-11-21]. https://www.researchgate.net/publication/228593520_SUS_A_quick_and_dirty_usability_scale

  BACKGROUND

MeSH Terms

Conditions

Epilepsy; Intellectual Disability; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Digital Health and Clinical Artificial Intelligence

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 3, 2026
• Study Start: October 12, 2024
• Primary Completion: November 12, 2025
• Study Completion: March 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)