Epilepsy
Conditions
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.
Interventions
None listed
Sponsors
Neuronostics Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis | 6 months | To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis |
Contacts
Primary ContactMilaana Mainstone
Outcome results
None listed