Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
- Conditions
- Epilepsy
- Interventions
- Device: EEG SubQ subcutaneous EEG device
- Registration Number
- NCT06144047
- Lead Sponsor
- King's College London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epilepsy EEG SubQ subcutaneous EEG device 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Participant adherence with 24/7 EEG™ SubQ Solution 6 months Wear time
Device deficiency 6 months Number of Device deficiencies
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
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
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
participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution baseline, 2 months and 6 months Post-market surveillance questionnaire
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
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
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
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
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
Trial Locations
- Locations (1)
King's College London
🇬🇧London, United Kingdom