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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult (age 18 and above) presenting with first suspected seizure(s) - Able to give willing to sign a consent form - Patient receives EEG following clinicians' decision to refer for an EEG based on clinical history and seizure description taken during first seizure clinic. Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. 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)

Treatments Being Tested

DEVICE

BioEP

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).

Locations (2)

Royal Cornwall Hospitals Trust
Truro, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom