Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

Study Overview
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Brief Summary
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The study will investigate whether a novel method to accurately count epileptic seizures, using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a participant-reported seizure diary; (ii) is feasible and acceptable to participants and clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides gains to the healthcare system when rolled-out into the National Health Service (NHS). 33 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and will collect data for six months. Annotated seizures from the EEG data will be sent weekly to the treating clinicians, who will communicate with the participants on a monthly basis, and will be free to make any management changes.

Official Title
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Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)

Conditions
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Epilepsy

Intervention / Treatment
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* Device: EEG SubQ subcutaneous EEG device


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have given written informed consent Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes. Adults (≥18 years of age) Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study. Experiencing ≥10 seizures per year according to their existing seizure diary. Willing and able to comply with study procedures Key Exclusion Criteria: Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures) Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Epilepsy<br>33 participants with drug-resistant epilepsy will be implanted with the EEGTM SubQ device under local anaesthesia, and will collect 2-channel EEG data, as well as completing an electronic seizure diary, for 6 months | Device: EEG SubQ subcutaneous EEG device<br>* 2-channel subcutaneous EEG device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution | Within-participant correlation between seizure counts per month estimated from rapid review of annotated 24/7 EEG™ SubQ data and 'ground truth' EEG seizure occurrences per month | 6 months | 
| Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary | Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month | 6 months | 
| Clinician rating of accuracy of 24/7 EEG SubQ | Clinician rating of accuracy of 24/7 EEG SubQ solution | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical relevance of the 24/7 EEG SubQ solution | Change over time for average Health Care Professional (HCP) questionnaires 'Communication', 'Insight' & 'Potential of 24/7 EEG™' scores | baseline, 2 months and 6 months | 
| Proportion of treating clinicians changing clinical management | Proportion of treating clinicians changing clinical management throughout the study due to information from the 24/7 EEG SubQ Solution | months 1, 2, 3, 4, 5, 6 | 
| Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ | Participants overall rating of the value of receiving feedback about seizures occurrences every month, across the full study period, from the EEG data recorded with 24/7 EEG™ SubQ | 6 months | 
| participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution | Post-market surveillance questionnaire | baseline, 2 months and 6 months | 
| Participant adherence with 24/7 EEG™ SubQ Solution | Wear time | 6 months | 
| Device deficiency | Number of Device deficiencies | 6 months | 
| EQ-5D-5L score | Change over time for average EQ-5D-5L scores at baseline, 2- months and 6 months | baseline, 2 months and 6 months | 
| Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score | Change over time for average Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) scores at baseline, 2-months and 6 months | baseline, 2 months and 6 months | 
| Impact of epilepsy score | Change over time for average Impact of epilepsy score at baseline, 2-months and 6 months | baseline, 2 months and 6 months | 
| Perceived Self-Mastery Over Epilepsy score | Change over time for average Perceived Self-Mastery Over Epilepsy score at baseline, 2-months and 6 months | baseline, 2 months and 6 months | 
| health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution | Client Services Receipt Inventory (CSRI) scores at 6 months | 6 months | 
| health economic impact of epilepsy for participants compared to historical controls | Client Services Receipt Inventory (CSRI) score at 6 months compared with the 138 participants in SMILE study in the treatment-as-usual arm | 6 months | 
| Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution | Quality-adjusted life-years (QALYs) score | 6 months | 
| EQ-5D-5L score comparison with historical controls | EQ-5D-5L score compared with the 138 participants in SMILE study in the treatment-as-usual arm | 6 months | 
| Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls | Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score compared with the 138 participants in SMILE study in the treatment-as-usual arm | 6 months | 
| Impact of epilepsy score comparison with historical controls | Impact of epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm | 6 months | 
| Perceived Self-Mastery Over Epilepsy score comparison with historical controls | Perceived Self-Mastery Over Epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable devices, epilepsy, EEG, subcutaneous EEG, mobile devices