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RECRUITING
NCT06097195
NA

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Sponsor: Neuronostics Ltd

View on ClinicalTrials.gov

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.

Official title: A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

559

Start Date

2024-05-21

Completion Date

2027-07-01

Last Updated

2024-08-09

Healthy Volunteers

No

Conditions

Interventions

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