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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IEEG-forecast | Experimental | Potentially informative seizure forecast. |
|
| Control-forecast | Active Comparator | Uninformative control seizure forecast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seizure risk forecast | Other | Participants are provided with daily risk estimates about upcoming seizure likelihood. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forecast performance | Performance of double-blinded (covert phase) IEEG-forecasts. Performance is quantified as the area-under-the sensitivity vs. time in warning curve (AUC) and double-tested statistically in a pairwise manner against shuffled chance-forecasts and participant's self-forecasts. | At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of forecast performance | For the cohort that progresses to the overt phase, The AUC obtained during the overt phase will be compared to their historical AUC during the covert phase and tested for a pairwise difference. | At least 8 seizures during the overt phase, expected to last 6-12 months |
| Informativity |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure rate | Participant's seizure rate in each phase of the trial expressed as the probability of a seizure per day. | Upon completion of each phase, after 6-12, 12-24 and 18-30 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxime O Baud, MD, PhD | Department of Neurology, Inselspital Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
The individual participant data can be shared by the investigators upon study completion based on a reasonable request.
The data will be shared 2-4 years after study start and up to a duration of 10 years.
Researcher will be able to access the data.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Three sequential phases:
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| Control seizure risk forecast | Other | Participant receive uninformative control forecast |
|
Participant-reported estimates of how informative a forecast is on a visual-analogue scale, scored from 0 to 10. |
| Throughout the open-label (6-12 months) and withdrawal phase (3-6 months) |
| QOLIE-31 | Quality Of Life In Epilepsy questionnaires with 31 items (QOLIE-31) completed at the transition from one study phase to the next. The quantification is on a scale from 0 to 100 and pairwise comparison between covert, overt and withdrawal phase. | Upon completion of the study after 18-30 months. |
| Actionability | List of concrete strategies enabled by the forecasts | End of open-label phase after 12-24 months. |