Clinical trial NCT06144047: Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG
Official title: Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
EEG
subcutaneous EEG
mobile devices
wearable devices
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2023-11-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution
timeFrame: 6 months
measure: Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary
timeFrame: 6 months
measure: Clinician rating of accuracy of 24/7 EEG SubQ
timeFrame: 6 months
Secondary outcomes:
measure: Clinical relevance of the 24/7 EEG SubQ solution
timeFrame: baseline, 2 months and 6 months
measure: Proportion of treating clinicians changing clinical management
timeFrame: months 1, 2, 3, 4, 5, 6
measure: Participants' perception of the value of receiving feedback about seizure occurrences estimated from EEG data recorded with 24/7 EEG™ SubQ
timeFrame: 6 months
measure: participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution
timeFrame: baseline, 2 months and 6 months
measure: Participant adherence with 24/7 EEG™ SubQ Solution
timeFrame: 6 months
measure: Device deficiency
timeFrame: 6 months
measure: EQ-5D-5L score
timeFrame: baseline, 2 months and 6 months
measure: Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score
timeFrame: baseline, 2 months and 6 months
measure: Impact of epilepsy score
timeFrame: baseline, 2 months and 6 months
measure: Perceived Self-Mastery Over Epilepsy score
timeFrame: baseline, 2 months and 6 months
measure: health economic impact of epilepsy for participants that have used the 24/7 EEG™ SubQ Solution
timeFrame: 6 months
measure: health economic impact of epilepsy for participants compared to historical controls
timeFrame: 6 months
measure: Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution
timeFrame: 6 months
measure: EQ-5D-5L score comparison with historical controls
timeFrame: 6 months
measure: Participant Weighted Quality of Life In Epilepsy (QOLIE-31-P) score comparison with historical controls
timeFrame: 6 months
measure: Impact of epilepsy score comparison with historical controls
timeFrame: 6 months
measure: Perceived Self-Mastery Over Epilepsy score comparison with historical controls
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Mark P Richardson
role: PRINCIPAL_INVESTIGATOR
References: