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

Epilepsy Clinical Trial

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

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144047
Study type Interventional
Source King's College London
Contact Eren Dursun
Phone +44 (0)20 7836 5454
Email eren.dursun@kcl.ac.uk
Status Recruiting
Phase N/A
Start date July 18, 2023
Completion date September 30, 2025
View Details
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