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

Neuronostics

Status

Not yet enrolling

Conditions

Epilepsy

Study type

Observational

Funder types

Industry

Identifiers

NCT06669364

NNBioEP003

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.