NCT06144047

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	EEG SubQ subcutaneous EEG device	2-channel subcutaneous EEG device

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-11-22
• Last updated: 2023-11-22

Locations

1 site across 1 country: United Kingdom