EpilepsyNCT07385157
Ultra-long-term EEG Monitoring in PwID
An observational study of Epilepsy and Intellectual Disability, Mild to Moderate, run by University of Plymouth at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Intellectual Disability, Mild to Moderate
- What is being tested?
- A minimally-invasive EEG monitoring device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cornwall Partnership NHS Foundation Trust
Truro, TR4 9LD
About this study
Official title: Acceptability and Impact of Ultra-long-term Subcutaneous EEG Monitoring in People With Epilepsy and Intellectual Disability
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.
Read more
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.
- Being tested
- A minimally-invasive EEG monitoring device
- Keywords
- Epilepsy, Intellectual Disability, Persons with Mental Disabilities, Electroencephalography, Seizures, Monitoring, Ambulatory
- Medical subject headings
- Epilepsy, Intellectual Disability, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A minimally-invasive EEG monitoring deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: A minimally-invasive EEG monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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].
Measured: At 6 months post-implantation of the device
Secondary outcomes (12)
Device safety
The safety of real-world implementation with 24/7 EEG SubQ Solution in this population will be assessed using the number of adverse events reported during the study period.
Measured: From implantation to explantation of the device
Seizure detection accuracy
The accuracy of seizure detection will be measured by calculating within-participant correlation between seizure counts per month from participant-reported seizure diary and occurrences per month (derived from EEG expert review and annotation of 24/7 EEG SubQ EEG data).
Measured: Across 6 months post-implantation of the device
Patients' quality of life
The Impact of real-world implementation of the SubQ on quality of life will be measured by the change over time for average Health of the Nation Outcome Scales for people with intellectual disability (HoNOS-ID) scores. The HoNOS-ID includes 18 items, all of which are rated on a 5-point scale from 0 (no problem during the period rated) to 4 (very severe problem) [2].
Measured: At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation
Patient behaviour
The perceived impact of the intervention on patient behaviour will be assessed using the Aberrant Behaviour Checklist (ABC). It includes 58 items, whic are rated on a 4-point scale "from 0 (not at all a problem) to 3 (the problem is severe in degree)" [3].
Measured: At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation
Satisfaction with the device in daily activities
Patients' satisfaction with the device in daily activities will be assessed using the customised Ease of use scale. This scale consists of 3 items rated on a 1-5 Likert scale, where 1 indicates the most favorable experience (e.g., never limited, very acceptable, never disturbed) and 5 indicates the least favorable experience (e.g., always limited, very unacceptable, always disturbed).
Measured: At 6 months post-implantation of the device
Impact of the device on everyday life
The impact of the device on patients' everyday life will be assessed using a customised questionnaire (named 'Everyday life'). This questionnaire consists of a 5-point rating of overall impact with a free-text explanation of the reasons behind that experience. For the rating, scores range from 1 to 5, where 1 indicates a very positive impact on managing epilepsy in everyday life, and 5 indicates a very negative impact.
Measured: At 6 months post-implantation of the device
Impact of the device on epilepsy management plans
The impact of the device on epilepsy management plans is measured using a customised questionnaired named 'Epilepsy Management Plan. This questionnaire consists of 5 descriptive items about changes to the epilepsy management plan, reasons for any changes, the role of 24/7 EEG SubQ data in those decisions, the types of adjustments made, and the reasons for not making changes when applicable.
Measured: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on management of epilepsy
The impact of the device on management of epilepsy is measured by using a customised questionnaire named 'Management. This questionnaire will be completed by healthcare professionals. It includes three 5-point Likert-scale questions (scored from 1 to 5, where 1 represents a very negative impact or strong disagreement and 5 represents a very positive impact or strong agreement) and two free-text questions about how UNEEG device data influence healthcare professionals' epilepsy management, confidence, and perceptions of patient engagement.
Measured: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on communication with carers
The impact of the device on communication with carers about the patient's epilepsy will be assessed using a customised questionnaired named 'Communication'. This questionnaire includes one 5-point Likert-scale question (scored from 1 to 5, where 1 indicates a very negative impact and 5 indicates a very positive impact on the healthcare professional's conversation with the patient's carer) and one free-text question exploring the reasons behind such an impact.
Measured: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on insights about the patient's epilepsy
The Impact of the device on insights about the patient's epilepsy is measured using a customised questionnaire named 'Insight'. This questionnaire includes one 5-point Likert-scale question (scored from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement regarding the value of the device data for gaining insight into the patient's epilepsy) and two categorical questions about which epilepsy-related parameters and additional insights beyond standard of care and clinical data were identified or supported by the device data.
Measured: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Device potential in clinical practice
The potential of the UNEEG device in clinical practice for patients with epilepsy is measured by using a customised questionnaire named 'Potential of 24/7 EEG SubQ'. This questionnaire comprises two 11-point numerical rating questions (scored from 0 to 10, where 0 represents very unsatisfied/very unlikely and 10 represents very satisfied/very likely), five 5-point Likert-scale questions (scored from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement regarding the clinical value and impact of the device), and one free-text question about the perceived potential of the UNEEG device in clinical practice for patients with epilepsy and intellectual disability.
Measured: At 6 months post-implantation of the device
Device deficiency
Device deficiencies will be assessed by the number of device deficiencies reported during the study period.
Measured: From device implantation until explantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start12 Oct 2024
- Primary completion12 Nov 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, UNEEG Medical A/S
- Responsible party
- Principal investigator, Edward Meinert, PhD, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385157
- Sponsor's protocol ID
- 24NEU030
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient identifiable data will not be sold to any other party and will not be shared with any organisation unless they are a partner in the study and have an appropriate information sharing agreement in place.
Publications
[3] Farmer C, Aman MG. Aberrant Behavior Checklist. Encyclopedia of Autism Spectrum Disorders Springer New York; 2020;1-8.
[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]
[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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Impact of Ultra-long-term Subcutaneous EEG Monitoring in People With Epilepsy and Intellectual Disability
- ClinicalTrials.gov ID
- NCT07385157
- Acronym / sponsor ID
- 24NEU030
- Keywords
- Epilepsy, Intellectual Disability, Persons with Mental Disabilities, Electroencephalography, Seizures, Monitoring, Ambulatory
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- Newcastle University, UNEEG Medical A/S
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort in people with intellectual disability and epilepsy | – | Device: A minimally-invasive EEG monitoring deviceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A minimally-invasive EEG monitoring deviceThe 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. | Device | Cohort in people with intellectual disability and epilepsy |
Primary outcome
Device acceptability
Time frame: At 6 months post-implantation of the device
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.
Device adherence
Time frame: Across 6 months post-implantation of the device
The adherence to use of UNEEG SubQ device will be assessed using participants' percentage wear time with 24/7 EEG SubQ.
Device usability
Time frame: At 6 months post-implantation of the device
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].
12 secondary outcomes
Device safety
Time frame: From implantation to explantation of the device
Seizure detection accuracy
Time frame: Across 6 months post-implantation of the device
Patients' quality of life
Time frame: At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation
Patient behaviour
Time frame: At baseline pre-implantation and post-implantation, and at 3-months and 6 months post-implantation
Satisfaction with the device in daily activities
Time frame: At 6 months post-implantation of the device
Impact of the device on everyday life
Time frame: At 6 months post-implantation of the device
Impact of the device on epilepsy management plans
Time frame: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on management of epilepsy
Time frame: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on communication with carers
Time frame: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Impact of the device on insights about the patient's epilepsy
Time frame: At 3-months and 6 months post-implantation, and every time the clinician initiate a change in the patient's clinical management plan from device implantation untill explantation.
Device potential in clinical practice
Time frame: At 6 months post-implantation of the device
Device deficiency
Time frame: From device implantation until explantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background[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
- Individual participant dataSharing planned: No. Patient identifiable data will not be sold to any other party and will not be shared with any organisation unless they are a partner in the study and have an appropriate information sharing agreement in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Intellectual Disability, Mild to Moderate, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device acceptability (time frame: At 6 months post-implantation of the device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.