ULTRA U002
Research type
Research Study
Full title
Evaluation of the 24/7 EEG™ SubQ System for Ultra Long-Term Recording of Patients with Temporal Lobe Epilepsy.
IRAS ID
307732
Contact name
Besa Ziso
Contact email
Sponsor organisation
UNEEG Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
The aim of the study is to assess the safety and effectiveness of the 24/7 EEG™ SubQ system. 24/7 EEG™ SubQ system is an implantable electroencephalogram (EEG) device which is inserted below the skin. The EEG data collected from the device will be compared to video-EEG recording captured during inpatient admission as well as seizures reported by patients during the course of the study.
There are currently no devices that can offer long term monitoring of seizures in patients with epilepsy. If effective 24/7 EEG™ SubQ system will provide valuable information to clinicians regarding seizure frequency and in doing so improve management and treatment of epilepsy.
Patients with temporal lobe epilepsy would be eligible for this study which will run over the course of 2 years with a total of 5-6 sites included in United States and Europe.
In this 12-week study participants will be asked to have 24/7 EEG™ SubQ system device implanted under their skin. Patients will also be asked to record any seizures in a logbook and will be admitted for a period of inpatient video-EEG recording during the 12 weeks to compare the 24/7 EEG™ SubQ against what is considered the current gold standard in seizure diagnosis. The EEG and seizure log will be reviewed by two neurophysiologists and compared to the EEG data generated from the 24/7 EEG™ SubQ system.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0011
Date of REC Opinion
21 Mar 2022
REC opinion
Further Information Favourable Opinion