EpilepsyPRISTINENCT05764252
A Prospective Diagnostic Belief Updating Study to verIfy the Utility of BioEP in First Seizure Clinics.
An observational study of Epilepsy, run by Neuronostics Ltd at 1 site in United Kingdom.
Trial summary
The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are: Clinicians' perception of seizure probability. 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
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2023to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult (age 18 and above) presenting with first suspected seizure(s).
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.
Who cannot join
- Participants unable to tolerate an EEG test so no EEG data was 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
1 site in 1 country.
About this study
Official title: Utility of a Computational Biomarker (BioEP) in Supporting Clinicians' Decision Making in Patients Presenting to an Adult Epilepsy Service First-seizure Clinic: A Prospective Diagnostic Belief Updating Study.
The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are:
- Clinicians' perception of seizure probability.
- Clinicians' decision to recommend commencing or deferring ASM (anti-seizure medications)
- Clinicians' decision to refer for additional investigations/services.
Participants will consent to have their EEG (that is taken at their routine care) to be used in the study. There is not extra burden to the participants taking part in the study.
Read the detailed description
The accurate diagnosis and prognosis of epilepsy represents a significant unmet medical need. Due to the unpredictable nature of seizures, epilepsy is difficult to diagnose and treat. In the United Kingdom (UK), 125,000 people per annum are referred to first seizure clinics with suspected epilepsy of which 40,000 receive a confirmed diagnosis of epilepsy. Although diagnosing a patient with epilepsy is a clinical decision, clinicians often look towards diagnostic tests (such as electroencephalograms - EEGs) to support their decision-making process. At present, in the absence of observable epileptiform abnormalities (abnormal wave forms strongly associated with epilepsy on EEG, there are no clinically robust markers of epilepsy. Mathematical models provide a powerful and useful tool with which to identify and understand biological mechanisms that may lead to the risk of having seizures. By combining mathematical and computational techniques, Neuronostics have developed a biomarker called BioEP. Using properties in the background and clinically non contributary EEG, the investigators have demonstrated in retrospective, multi-site phase I and phase II studies sufficient evidence that could support clinicians to make more informed diagnostic decisions that investigators hope will lead to better and faster decisions about patients' diagnosis and treatment. The investigators will now conduct a prospective single site diagnostic belief updating study to examine the utility of BioEP in supporting clinicians' decision making a clinical setting in the NHS. The investigators will do this by inviting adults to take part who are suspected of having a first seizure and who will attend a first seizure clinic run by a Consultant Nurse for the Epilepsies (CNE) at the Royal Wolverhampton NHS trust. As part of the patients diagnostic work up, patients will have an EEG performed, the investigators will then apply BioEP to the patients EEG to derive a "risk score". This risk score will be presented to the CNE, who may then decide to combine it with the clinical history and clinical test information to help the CNE make decisions about patients' diagnosis and treatment.
The CNE will first rate the probability that the patient has experienced an epileptic seizure and probability of recurrence based on the clinical history and standard EEG (and any other standard tests ordered). A second assessment of this probability will be made after the CNE subsequently receives the BioEP risk score and report to quantify the updating of belief (that the patient has an increased seizure risk) and assess the utility of BioEP as a diagnostic decision support tool.
- Conditions
- Epilepsy
- Being tested
- BioEP
- Keywords
- Epilepsy, EEG, Biomarkers, diagnostic belief updating study, consultant nurse for the epilepsies, first seizure clinic, 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
All patient's EEG will have the BioEP score conducted on it
| Study group | Role | What they receive |
|---|---|---|
| BioEP | The EEG will be analysed using the BioEP algorithm Receives: Device: BioEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicians' perception of seizure probability in a 2 step process, using a 7-category scale and a 100-mm visual analogue scale
The clinician rates the probability that the patient will experience another epileptic seizure before and after the presentation of the BioEP score (updating beliefs). Using the clinician's ratings, we will impute the implicit individual likelihood ratios - the factor changes in the perceived odds of the patient experiencing another epileptic seizure based on the updated beliefs in the face of new evidence (the BioEP score)
Measured: 1 day
Number of additional patient's investigations/services
Clinicians' decision-making over time will be explored. When patients present multiple times over a period, more clinical information is gathered and thus clinicians' perception of the probability of a seizure may change as evidence increases. The influence of multiple presentations and investigations shall be considered and reported descriptively. Any additional EEGs performed in the 1-year follow up period shall be analysed by our methods. The risk score will be presented to the CNE, who may then decide to combine it with any new emerging clinical history and clinical test information to help the CNE make any further decisions about patients' diagnosis and treatment.
Measured: 1 year
Number of Clinicians' decisions to recommend commencing or deferring anti-seizure medications (ASM)
Clinicians' decision-making over time will be explored. The decisions to recommend commencing or deferring ASMs will be recorded.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start23 Aug 2023
- Primary completion7 Aug 2024
- Study completionSep 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
- Prospective
- Enrolment
- 88 participants (actual)
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
- NCT05764252
- Sponsor's protocol ID
- NNBioEP001
- Acronym
- PRISTINE
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2023
- Last updated
- 12 Aug 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of a Computational Biomarker (BioEP) in Supporting Clinicians' Decision Making in Patients Presenting to an Adult Epilepsy Service First-seizure Clinic: A Prospective Diagnostic Belief Updating Study.
- ClinicalTrials.gov ID
- NCT05764252
- Acronym / sponsor ID
- PRISTINE / NNBioEP001
- Conditions
- Epilepsy
- Keywords
- Epilepsy, EEG, Biomarkers, diagnostic belief updating study, consultant nurse for the epilepsies, first seizure clinic, BioEP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Neuronostics LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Mar 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.
The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are:
- Clinicians' perception of seizure probability.
- Clinicians' decision to recommend commencing or deferring ASM (anti-seizure medications)
- Clinicians' decision to refer for additional investigations/services.
Participants will consent to have their EEG (that is taken at their routine care) to be used in the study. There is not extra burden to the participants taking part in the study.
Detailed description
The accurate diagnosis and prognosis of epilepsy represents a significant unmet medical need. Due to the unpredictable nature of seizures, epilepsy is difficult to diagnose and treat. In the United Kingdom (UK), 125,000 people per annum are referred to first seizure clinics with suspected epilepsy of which 40,000 receive a confirmed diagnosis of epilepsy. Although diagnosing a patient with epilepsy is a clinical decision, clinicians often look towards diagnostic tests (such as electroencephalograms - EEGs) to support their decision-making process. At present, in the absence of observable epileptiform abnormalities (abnormal wave forms strongly associated with epilepsy on EEG, there are no clinically robust markers of epilepsy. Mathematical models provide a powerful and useful tool with which to identify and understand biological mechanisms that may lead to the risk of having seizures. By combining mathematical and computational techniques, Neuronostics have developed a biomarker called BioEP. Using properties in the background and clinically non contributary EEG, the investigators have demonstrated in retrospective, multi-site phase I and phase II studies sufficient evidence that could support clinicians to make more informed diagnostic decisions that investigators hope will lead to better and faster decisions about patients' diagnosis and treatment. The investigators will now conduct a prospective single site diagnostic belief updating study to examine the utility of BioEP in supporting clinicians' decision making a clinical setting in the NHS. The investigators will do this by inviting adults to take part who are suspected of having a first seizure and who will attend a first seizure clinic run by a Consultant Nurse for the Epilepsies (CNE) at the Royal Wolverhampton NHS trust. As part of the patients diagnostic work up, patients will have an EEG performed, the investigators will then apply BioEP to the patients EEG to derive a "risk score". This risk score will be presented to the CNE, who may then decide to combine it with the clinical history and clinical test information to help the CNE make decisions about patients' diagnosis and treatment.
The CNE will first rate the probability that the patient has experienced an epileptic seizure and probability of recurrence based on the clinical history and standard EEG (and any other standard tests ordered). A second assessment of this probability will be made after the CNE subsequently receives the BioEP risk score and report to quantify the updating of belief (that the patient has an increased seizure risk) and assess the utility of BioEP as a diagnostic decision support tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioEP | – | Device: BioEPThe EEG will be analysed using the BioEP algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (age 18 and above) presenting with first suspected seizure(s).
Key inclusion criteria (3 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.
Key exclusion criteria (3 listed)
- Participants unable to tolerate an EEG test so no EEG data was 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 |
|---|---|---|
| BioEPAll patient's EEG will have the BioEP score conducted on it | Device | BioEP |
Primary outcome
Clinicians' perception of seizure probability in a 2 step process, using a 7-category scale and a 100-mm visual analogue scale
Time frame: 1 day
The clinician rates the probability that the patient will experience another epileptic seizure before and after the presentation of the BioEP score (updating beliefs). Using the clinician's ratings, we will impute the implicit individual likelihood ratios - the factor changes in the perceived odds of the patient experiencing another epileptic seizure based on the updated beliefs in the face of new evidence (the BioEP score)
Number of additional patient's investigations/services
Time frame: 1 year
Clinicians' decision-making over time will be explored. When patients present multiple times over a period, more clinical information is gathered and thus clinicians' perception of the probability of a seizure may change as evidence increases. The influence of multiple presentations and investigations shall be considered and reported descriptively. Any additional EEGs performed in the 1-year follow up period shall be analysed by our methods. The risk score will be presented to the CNE, who may then decide to combine it with any new emerging clinical history and clinical test information to help the CNE make any further decisions about patients' diagnosis and treatment.
Number of Clinicians' decisions to recommend commencing or deferring anti-seizure medications (ASM)
Time frame: 1 year
Clinicians' decision-making over time will be explored. The decisions to recommend commencing or deferring ASMs will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Related trials for Epilepsy
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory 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. This study is not recruiting at the moment.
Milaana Mainstone study director
Neuronostics Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Neuronostics Ltd at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicians' perception of seizure probability in a 2 step process, using a 7-category scale and a 100-mm visual analogue scale (time frame: 1 day). The study lists 3 primary outcomes in all. 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 12 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.