The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
Recruiting · NCT06097195 · Interventional (participants receive a specific treatment) · Lead sponsor: Neuronostics Ltd
View the official record on ClinicalTrials.gov →Interventions studied
BioEP
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed.
- Royal Cornwall Hospitals Trust - Truro, United Kingdom
- The Royal Wolverhampton NHS Trust - Wolverhampton, United Kingdom