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NCT06097195Recruiting

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the 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 Neuronostics to iterate the BioEP algorithms and so improve future performance.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
559 (estimated)
First submitted
18 Oct 2023
Start date
21 May 2024
Primary completion date
31 Mar 2026
Lead sponsor
Neuronostics Ltd
Diseases
Epilepsy
NCT number
NCT06097195

What you commit to

  • Study type: Interventional
  • Planned participants: 559
  • From 21 May 2024 to the primary completion date, 31 Mar 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy (e.g. vasovagal syncope)

Other

  • Participants unable to tolerate an EEG test so no EEG data were gathered
  • Participants with a known hepatic/renal encephalopathy

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Cornwall Hospitals Trust
Coordinator of this site? Confirm its status
TruroUnited KingdomRecruiting
The Royal Wolverhampton NHS Trust
Coordinator of this site? Confirm its status
WolverhamptonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.