The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Official title

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

Overview

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.

Detailed description

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.

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 mathemati

Primary outcome measures

• The primary outcome is epilepsy diagnosis (yes/no) at baseline. [Time frame: Baseline]

Secondary outcome measures (1)

• Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy [Time frame: 1 year and 2 year]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United Kingdom · 2 centers

• Royal Cornwall Hospitals Trust — Truro
• The Royal Wolverhampton NHS Trust — Wolverhampton

Identifiers

NCT: NCT06097195 · NNBioEP002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗