EpilepsySOLITAIRENCT06669364
A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility
An observational study of Epilepsy, run by Neuronostics Ltd.
Trial summary
The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are: To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2025
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult population with a diagnosis of epilepsy
Who may be able to join
- Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
- A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
- EEGs performed to ABRET \& IFCN standards using a minimum of 19 electrodes and additional technical requirements.
Who cannot join
- Subject was not suspected of having had a seizure or epilepsy.
- Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
- Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
- Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
- Sleep deprived EEG recordings in the outpatient setting.
- Encephalopathic subjects.
- Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.
- Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.
The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:
- To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
- To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Device: BioEP All patient's EEG will have the BioEP score conducted on it | |
| Non-epilepsy | Device: BioEP All patient's EEG will have the BioEP score conducted on it |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
Diagnostic accuracy, defined by a primary endpoint family1 of two ranked endpoints. Specifically, we are testing whether BioEP has superior sensitivity to initial EEG alone and is no worse than EEG alone for specificity (non-inferiority). These are ranked hypotheses with sensitivity taking precedence (fixed sequence method) . That is, we shall only proceed to comparing specificity if sensitivity is superior.
Measured: 6 months
Secondary outcomes (1)
To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis
To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milaana Mainstone, Study director, Neuronostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669364
- Sponsor's protocol ID
- NNBioEP003
- Acronym
- SOLITAIRE
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.
- ClinicalTrials.gov ID
- NCT06669364
- Acronym / sponsor ID
- SOLITAIRE / NNBioEP003
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Neuronostics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Nov 2024 (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.
The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:
- To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
- To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | – | –Device: BioEP All patient's EEG will have the BioEP score conducted on it |
| Non-epilepsy | – | –Device: BioEP All patient's EEG will have the BioEP score conducted on it |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with a diagnosis of epilepsy
Key inclusion criteria (3 listed)
- Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
- A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
- EEGs performed to ABRET \& IFCN standards using a minimum of 19 electrodes and additional technical requirements.
Key exclusion criteria (8 listed)
- Subject was not suspected of having had a seizure or epilepsy.
- Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
- Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
- Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
- Sleep deprived EEG recordings in the outpatient setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
Time frame: 6 months
Diagnostic accuracy, defined by a primary endpoint family1 of two ranked endpoints. Specifically, we are testing whether BioEP has superior sensitivity to initial EEG alone and is no worse than EEG alone for specificity (non-inferiority). These are ranked hypotheses with sensitivity taking precedence (fixed sequence method) . That is, we shall only proceed to comparing specificity if sensitivity is superior.
1 secondary outcome
To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis
Time frame: 6 months
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 1 Nov 2024.
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
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.
Milaana Mainstone study director
Neuronostics Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Neuronostics Ltd.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Milaana Mainstone (+44 (0)117 457 2292, m.mainstone@neuronostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis (time frame: 6 months). 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 1 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.