PRISTINE
Research type
Research Study
Full title
Utility of a computational biomarker (BioEP) in supporting clinicians’ decision-making in patients presenting to an Adult Epilepsy Service first-seizure clinic: A prospective diagnostic belief updating study.
IRAS ID
321340
Contact name
Phil Tittensor
Contact email
Sponsor organisation
Neuronostics
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 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 will now conduct a prospective single site diagnostic belief updating study to examine the utility of BioEP in supporting clinicians’ decision-making in a clinical setting. We will do this by inviting adults to take part who are suspected of having a first seizure and who will attend a first seizure clinic run by a Consultant Nurse for the Epilepsies (CNE) at the Royal Wolverhampton NHS trust.
The CNE will first rate the probability that the patient has experienced an epileptic seizure and probability of recurrence based on the clinical history and standard EEG (and any other standard tests ordered). A second assessment of this probability will be made after the CNE subsequently receives the BioEP risk score and report to quantify the updating of belief (that the patient has an increased seizure risk) and assess the utility of BioEP as a diagnostic decision support tool.
This is a 2 year study - 1 year recruitment and 1 year follow up. Participants will have routine standard of care.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
23/WM/0083
Date of REC Opinion
15 May 2023
REC opinion
Further Information Favourable Opinion