NCT06097195 The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
| NCT ID | NCT06097195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuronostics Ltd |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 559 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 559 participants in total. It began in 2024-05-21 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Wessel Woldman
STUDY DIRECTOR
Neuronostics Ltd
Frequently Asked Questions
Who can join the NCT06097195 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06097195 currently recruiting?
Yes, NCT06097195 is actively recruiting participants. Contact the research team at w.woldman@neuronostics.com for enrollment information.
Where is the NCT06097195 trial being conducted?
This trial is being conducted at Truro, United Kingdom, Wolverhampton, United Kingdom.
Who is sponsoring the NCT06097195 clinical trial?
NCT06097195 is sponsored by Neuronostics Ltd. The principal investigator is Wessel Woldman at Neuronostics Ltd. The trial plans to enroll 559 participants.
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