Epilepsy
Conditions
Keywords
epilepsy, EEG, subcutaneous EEG, mobile devices, wearable devices
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.
Interventions
DEVICEEEG SubQ subcutaneous EEG device
2-channel subcutaneous EEG device
Sponsors
King's College Hospital NHS Trust
King's College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactEren Dursun
Backup ContactMark P Richardson
Outcome results
None listed