EpilepsyCITADELNCT06097195
The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
A study testing BioEP in people with Epilepsy, run by Neuronostics Ltd at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- BioEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 559 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Verity Fuller contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Cornwall Hospitals Trust
Truro
Milaana Mainstone
- Recruiting
The Royal Wolverhampton NHS Trust
Wolverhampton
Milaana Mainstone
About this study
Official title: A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- BioEP
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioEPDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participant has usual care |
| Usual Care + BioEP | Other | Participant has usual care + BioEP algorithm on their EEG Receives: Device: BioEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy
The accuracy of the initial BioEP score will be evaluated prospectively
Measured: 1 year and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start21 May 2024
- Primary completion31 Mar 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 559 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wessel Woldman, Study director, Neuronostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097195
- Sponsor's protocol ID
- NNBioEP002
- Acronym
- CITADEL
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Prospective, Two-arm Randomised Controlled Trial to Determine the Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy
- ClinicalTrials.gov ID
- NCT06097195
- Acronym / sponsor ID
- CITADEL / NNBioEP002
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 559 participants (estimated)
- Lead sponsor
- Neuronostics LtdIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participant has usual care |
| Usual Care + BioEP | Other | Device: BioEPParticipant has usual care + BioEP algorithm on their EEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioEPWhen 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). | Device | Usual Care + BioEP |
Primary outcome
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.
1 secondary outcome
Accuracy of the BioEP score in predicting subsequent confirmation of epilepsy
Time frame: 1 year and 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Verity Fuller contact
Wessel Woldman study director
Neuronostics Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioEP in people with Epilepsy, run by Neuronostics Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wessel Woldman (+44 (0)117 457 2292, w.woldman@neuronostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is epilepsy diagnosis (yes/no) at baseline. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.