A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility
ConditionEpilepsy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorNeuronostics Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov