NCT05764252

Brief 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.
  • 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 12, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

February 15, 2023

Last Update Submit

August 7, 2024

Conditions

Epilepsy

Keywords

EpilepsyEEGBiomarkersdiagnostic belief updating studyconsultant nurse for the epilepsiesfirst seizure clinicBioEP

Outcome Measures

Primary Outcomes (3)

  • 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)

    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.

    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.

    1 year

Study Arms (1)

BioEP

The EEG will be analysed using the BioEP algorithm

Device: BioEP

Interventions

BioEPDEVICE

All patient's EEG will have the BioEP score conducted on it

BioEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult (age 18 and above) presenting with first suspected seizure(s).

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phil Tittensor

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Milaana Mainstone

    Neuronostics Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 10, 2023

Study Start

August 23, 2023

Primary Completion

August 7, 2024

Study Completion

September 1, 2025

Last Updated

August 12, 2024

Record last verified: 2024-04

Locations

GB(1)