Evaluating BioEP for diagnosing epilepsy
A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
NA · Neuronostics Ltd · NCT06097195
This study is testing if adding a new BioEP score to regular care can help doctors better diagnose adults who might have epilepsy after their first seizure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 559 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuronostics Ltd (industry) |
| Locations | 2 sites (Truro and 1 other locations) |
| Trial ID | NCT06097195 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the clinical utility of BioEP in improving diagnostic decision-making for patients suspected of having epilepsy. It involves a two-arm randomized control trial where participants will either receive usual care or usual care supplemented with a BioEP score and report. The study will recruit adults attending first seizure clinics across 10 sites, with a recruitment period of one year followed by a two-year follow-up. The goal is to enhance the Neuronostics platform and improve future performance of BioEP algorithms based on trial findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above who are presenting with their first suspected seizure and can provide informed consent.
Not a fit: Patients who cannot tolerate an EEG or have a clear diagnosis of a condition other than epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of epilepsy, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing diagnostic accuracy in epilepsy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age 18 and above) presenting with first suspected seizure(s) * Able to give informed consent * Patient receives EEG following clinicians' decision to refer for an EEG based on clinical history and seizure description taken during first seizure clinic. * Non-contributory EEG only (i.e. no specific diagnostic abnormalities present such as interictal epileptiform discharges) Exclusion Criteria: * Participants unable to tolerate an EEG test so no EEG data were gathered * Participants with a known hepatic/renal encephalopathy * Participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy (e.g. vasovagal syncope)
Where this trial is running
Truro and 1 other locations
- Royal Cornwall Hospitals Trust — Truro, United Kingdom (RECRUITING)
- The Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Wessel Woldman
- Email: w.woldman@neuronostics.com
- Phone: +44 (0)117 457 2292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy