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The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
Sponsor: Neuronostics Ltd
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
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