Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epilepsy | Device: BioEP All patient's EEG will have the BioEP score conducted on it | ||
| Non-epilepsy | Device: BioEP All patient's EEG will have the BioEP score conducted on it |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult population with a diagnosis of epilepsy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milaana Mainstone | Contact | +44 (0)117 457 2292 | m.mainstone@neuronostics.com |
| Name | Affiliation | Role |
|---|---|---|
| Milaana Mainstone | Neuronostics Ltd | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided