Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

Epilepsy Clinical Trial

— REAL-ASE  

Official title:

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144047
• Other study ID #: IRAS: 324630
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: Eren Dursun
• Phone: +44 (0)20 7836 5454
• Email: eren.dursun[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• EEG SubQ subcutaneous EEG device
2-channel subcutaneous EEG device

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinician rating of accuracy of 24/7 EEG SubQ	Clinician rating of accuracy of 24/7 EEG SubQ solution	6 months
Secondary	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
Secondary	Proportion of treating clinicians changing clinical management	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
Secondary	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
Secondary	participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution	Post-market surveillance questionnaire	baseline, 2 months and 6 months
Secondary	Participant adherence with 24/7 EEG™ SubQ Solution	Wear time	6 months
Secondary	Device deficiency	Number of Device deficiencies	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness of current practice and 24/7 EEG™ SubQ Solution	Quality-adjusted life-years (QALYs) score	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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