Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.

Neuronostics Ltd0 sites400 target enrollmentJanuary 1, 2025

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: Neuronostics Ltd
Enrollment: 400
Primary Endpoint: To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

March 1, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Neuronostics Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.