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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Epilepsy

Device: BioEP

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

No interventions assigned to this group

Non-epilepsy

Device: BioEP

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No