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

Not yet recruiting

• Conditions: Epilepsy

• Registration Number: NCT06669364
• Lead Sponsor: Neuronostics Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-07
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Study Start: 2025-01-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis	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.

Secondary Outcome Measures

Name	Time	Method
To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis	6 months	To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis