At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BioEP (device)
- How long the study runs
- Study runs about 31 months (dates as stated)
- About the drug or intervention
- BioEP — device: When a consenting participant has their first electroencephalogram (EEG), they will be assigned with a unique participant study identifier before being uploaded.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 559
- Started
- 2024-05-21
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for epilepsy
- • NA - 559 participants
- • Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with epilepsy
Where?
- • Truro - Royal Cornwall Hospitals Trust
- • Wolverhampton - The Royal Wolverhampton NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adult (age 18 and above) presenting with first suspected seizure(s)
- ✓Able to give agreement to take part
- ✓Patient receives EEG following clinicians' decision to refer for an EEG based on clinical history and seizure...
- ✓Non-contributory EEG only (i.e. no specific diagnostic abnormalities present such as interictal epileptiform discharges)
Who cannot take part
- ✗Participants unable to tolerate an EEG test so no EEG data were gathered
- ✗Participants with a known liver/kidney encephalopathy
- ✗Participants that upon history taking have a clear clinical diagnosis of a physical condition other than epilepsy...
See the full criteria
Where Is This Study? (2 UK sites)
Royal Cornwall Hospitals Trust
Truro, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
How to Get in Touch
Wessel Woldman
Sponsor contactCONTACT
Verity Fuller
Sponsor contactCONTACT