The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
CITADEL
A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
1 other identifier
interventional
559
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 24, 2023
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 21, 2026
April 1, 2026
1.9 years
October 18, 2023
April 16, 2026
Conditions
Outcome Measures
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.
Baseline
Secondary Outcomes (1)
Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy
1 year and 2 year
Study Arms (2)
Usual Care
NO INTERVENTIONParticipant has usual care
Usual Care + BioEP
OTHERParticipant has usual care + BioEP algorithm on their EEG
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuronostics Ltdlead
Study Sites (2)
Royal Cornwall Hospitals Trust
Truro, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wessel Woldman
Neuronostics Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2023
First Posted
October 24, 2023
Study Start
May 21, 2024
Primary Completion
March 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04