REAL-ASE: Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Epilepsy 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
2-channel subcutaneous EEG device
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution [6 months]
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
- Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary [6 months]
Within-participant correlation between seizure counts per month from participant-reported seizure diary and 'ground truth' EEG seizure occurrences per month
- Clinician rating of accuracy of 24/7 EEG SubQ [6 months]
Clinician rating of accuracy of 24/7 EEG SubQ solution
Secondary Outcome Measures
- Clinical relevance of the 24/7 EEG SubQ solution [baseline, 2 months and 6 months]
Change over time for average Health Care Professional (HCP) questionnaires 'Communication', 'Insight' & 'Potential of 24/7 EEG™' scores
- Proportion of treating clinicians changing clinical management [months 1, 2, 3, 4, 5, 6]
Proportion of treating clinicians changing clinical management throughout the study due to information from the 24/7 EEG SubQ Solution
- Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ [6 months]
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
- participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution [baseline, 2 months and 6 months]
Post-market surveillance questionnaire
- Participant adherence with 24/7 EEG™ SubQ Solution [6 months]
Wear time
- Device deficiency [6 months]
Number of Device deficiencies
- EQ-5D-5L score [baseline, 2 months and 6 months]
Change over time for average EQ-5D-5L scores at baseline, 2- months and 6 months
- Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score [baseline, 2 months and 6 months]
Change over time for average Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) scores at baseline, 2-months and 6 months
- Impact of epilepsy score [baseline, 2 months and 6 months]
Change over time for average Impact of epilepsy score at baseline, 2-months and 6 months
- Perceived Self-Mastery Over Epilepsy score [baseline, 2 months and 6 months]
Change over time for average Perceived Self-Mastery Over Epilepsy score at baseline, 2-months and 6 months
- health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution [6 months]
Client Services Receipt Inventory (CSRI) scores at 6 months
- health economic impact of epilepsy for participants compared to historical controls [6 months]
Client Services Receipt Inventory (CSRI) score at 6 months compared with the 138 participants in SMILE study in the treatment-as-usual arm
- Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution [6 months]
Quality-adjusted life-years (QALYs) score
- EQ-5D-5L score comparison with historical controls [6 months]
EQ-5D-5L score compared with the 138 participants in SMILE study in the treatment-as-usual arm
- Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls [6 months]
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
- Impact of epilepsy score comparison with historical controls [6 months]
Impact of epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
- Perceived Self-Mastery Over Epilepsy score comparison with historical controls [6 months]
Perceived Self-Mastery Over Epilepsy score compared with the 138 participants in SMILE study in the treatment-as-usual arm
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Have given written informed consent
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Diagnosis of treatment-resistant epilepsy of any syndrome in which seizures are detectable in scalp EEG with two electrodes.
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Adults (≥18 years of age)
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Participant routinely keeps a seizure diary, has a smartphone and is willing to use the electronic diary for the study.
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Experiencing ≥10 seizures per year according to their existing seizure diary.
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Willing and able to comply with study procedures
Key Exclusion Criteria:
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Established current diagnosis of psychogenic non-epileptic attacks (dissociative seizures)
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Frequent vigorous involuntary movements (eg. chorea, athetosis) or frequent parasomnias with major motor components (eg. sleep walking, night terrors)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King's College London | London | United Kingdom |
Sponsors and Collaborators
- King's College London
- King's College Hospital NHS Trust
Investigators
- Principal Investigator: Mark P Richardson, King's College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRAS: 324630