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
This trial does not accept healthy volunteersQualifiers
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 population
Adult population with a diagnosis of epilepsy
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Epilepsy
Group B: Non-epilepsy
Trial outcomes
Primary outcomes
1
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
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.
Time frame
6 monthsSecondary outcomes
1
To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis
To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: