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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
King's College London
RECRUITING
London
Contact Information
Primary
Eren Dursun
eren.dursun@kcl.ac.uk
+44 (0)20 7836 5454
Backup
Mark P Richardson
mark.richardson@kcl.ac.uk
+44 (0)20 7836 5454
Time Frame
Start Date: 2023-07-18
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 33
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: King's College Hospital NHS Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov