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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: EEG SubQ subcutaneous EEG device

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eren Dursun; Phone Number: +44 (0)20 7836 5454; Email: eren.dursun@kcl.ac.uk
• Study Contact Backup: Name: Mark P Richardson; Phone Number: +44 (0)20 7836 5454; Email: mark.richardson@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • King's College London
    • Contact: Eren Dursun; Email: eren.dursun@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Epilepsy; 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	Device: EEG SubQ subcutaneous EEG device; 2-channel subcutaneous EEG device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Mark P Richardson, King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Estimated): November 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: epilepsy; EEG; wearable devices; subcutaneous EEG; mobile devices
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: IRAS: 324630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No