A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility

NCT06669364 | Not Yet Recruiting

• 1 other identifier: NNBioEP003
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis

  6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult population with a diagnosis of epilepsy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuronostics Ltd: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Milaana Mainstone

  Neuronostics Ltd

  STUDY DIRECTOR

Central Study Contacts

Milaana Mainstone

CONTACT

+44 (0)117 457 2292; m.mainstone@neuronostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: November 1, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10