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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG SubQ subcutaneous EEG device | Device | 2-channel subcutaneous EEG device |
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| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eren Dursun | Contact | +44 (0)20 7836 5454 | eren.dursun@kcl.ac.uk | |
| Mark P Richardson | Contact | +44 (0)20 7836 5454 | mark.richardson@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mark P Richardson | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |