CITADEL
Research type
Research Study
Full title
A multi-centre, prospective, two-arm randomised controlled trial to determine the clinical utility of BioEP in diagnostic decision making in epilepsy
IRAS ID
333279
Contact name
Rohit Shankar
Contact email
Sponsor organisation
Neuronostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The accurate diagnosis and prognosis of epilepsy represents a significant unmet medical need. Due to the unpredictable nature of seizures, epilepsy is difficult to diagnose and treat. In the UK, 125,000 people are referred to first seizure clinics per annum with suspected epilepsy of which 40,000 receive a confirmed diagnosis of epilepsy. At present in the absence of observable epileptiform abnormalities (abnormal wave forms) on EEG; there are no clinically robust markers of epilepsy. By combining mathematical and computational techniques Neuronostics have developed a biomarker called BioEP, by using properties in the resting-state EEG we have demonstrated in phase I and phase II sufficient evidence that could guide clinicians to make more informed diagnostic decisions that we hope will lead to better and faster decisions about patients’ diagnosis and treatment.
We plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. We will use findings from the trial to improve user experience of our Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable us to iterate the BioEP algorithms and so improve future performance.
This is a 3 year study - 1 year recruitment and 2 year follow up.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0011
Date of REC Opinion
8 Feb 2024
REC opinion
Further Information Favourable Opinion