Status:
RECRUITING
The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
Lead Sponsor:
Neuronostics Ltd
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
Detailed Description
Neuronostics will conduct a two-arm randomised control trial with two groups: (i) Usual Care, (ii) Usual Care + BioEP score and report. In this context, usual care involves clinical/ patient history, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT06097195
Start Date
May 21 2024
End Date
July 1 2027
Last Update
August 9 2024
Active Locations (2)
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1
Royal Cornwall Hospitals Trust
Truro, United Kingdom
2
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom