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NCT Number: NCT06097195

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Cornwall Hospitals Trust, Truro, United Kingdom

Loading trial locations.

About this study

Neuronostics will conduct a two-arm randomised control trial with two groups: (i) Usual Care, (ii) Usual Care + BioEP score and report. In this context, usual care involves clinical/ patient history, eye-witness accounts and any standard tests ordered (electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), blood tests etc.). Investigators will recruit adults attending first seizure clinics where there is a suspicion that epilepsy is the causing symptoms and so a first EEG is recommended. Participants will be sourced from 10 sites. The trial duration will be 1 year recruitment, and 2 year follow up period.

Randomisation: Consenting individual patients will be randomly assigned to either Usual Care or Usual Care + BioEP in a 1:1 ratio. Randomisation will be stratified by centre, with eligible and consenting participants allocated in random blocks. The allocation schedule will be generated by the trial statistician, and concealed from the clinicians assessing eligibility and recruiting patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Non-contributory EEG only (i.e. no specific diagnostic abnormalities present such as interictal epileptiform discharges)

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)

Treatment and study plan

BioEP

Device

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).

Primary outcomes

  1. The primary outcome is epilepsy diagnosis (yes/no) at baseline.

    Time frame: 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.

Secondary outcomes

  1. Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy

    Time frame: 1 year and 2 year

    The accuracy of the initial BioEP score will be evaluated prospectively

Study contacts

Contact information is provided by the study sponsor or research team.

Verity Fuller

CONTACT

[email protected]

Wessel Woldman

CONTACT

[email protected]

+44 (0)117 457 2292

Sponsors and collaborators

Lead sponsor

Neuronostics Ltd

Industry

Registry information

Official study title

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

Acronym: CITADEL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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