RecruitingNot ApplicableNCT06097195

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

Sponsor

Neuronostics Ltd

Enrollment

559 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Epilepsy

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria3

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)

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Interventions

DEVICEBioEP

When 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).