Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

NCT06144047 | Unknown

• 1 other identifier: IRAS: 324630
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; EEG; subcutaneous EEG; mobile devices; wearable devices

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Clinical relevance of the 24/7 EEG SubQ solution

  baseline, 2 months and 6 months

• Proportion of treating clinicians changing clinical management

  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

  6 months

• participants' acceptability of real-world implementation with 24/7 EEG™ SubQ Solution

  baseline, 2 months and 6 months

• Participant adherence with 24/7 EEG™ SubQ Solution

  6 months

Study Arms (1)

Epilepsy

OTHER

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

Interventions

EEG SubQ subcutaneous EEG device DEVICE

2-channel subcutaneous EEG device

Epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

King's College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark P Richardson

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eren Dursun

CONTACT

+44 (0)20 7836 5454; eren.dursun@kcl.ac.uk

Mark P Richardson

CONTACT

+44 (0)20 7836 5454; mark.richardson@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 22, 2023
• Study Start: July 18, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-10

Locations

GB (1)