The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuronostics Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
BioEP
DeviceWhen a consenting participant has their first electroencephalogram (EEG), they will be assigned with a unique participant study identifier before being uploaded. The centre will convert the EEG to European Data Format (EDF) format (or upload the total file) and upload this to the Neuronostics platform. The EEG will be stored on the Neuronostics database management system, within which the computational and mathematical analysis will be carried out. This study involves data analysis and mathematical modelling of the EEG recordings of each patient individually to generate a computational analysis score (BioEP).
Treatment groups
559 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Usual Care + BioEPOther 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome is epilepsy diagnosis (yes/no) at baseline.
The epilepsy diagnosis timepoint is defined as the diagnostic decision of the clinician after the continuous process of information gathering, integration, and interpretation and deciding that sufficient information has been gathered to make a definitive judgment. Initial suspicions of a provoked or isolated seizure leading to a watch-and-wait strategy are not regarded as a epilepsy diagnosis.
Time frame
BaselineSecondary outcomes
1
Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy
The accuracy of the initial BioEP score will be evaluated prospectively
Time frame
1 year and 2 yearSponsors and contacts
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Source ClinicalTrials.gov