Epilepsy (Treatment Refractory)
Conditions
Keywords
Seizure forecasting
Brief summary
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.
Interventions
OTHERSeizure risk forecast
Participants are provided with daily risk estimates about upcoming seizure likelihood.
OTHERControl seizure risk forecast
Participant receive uninformative control forecast
Sponsors
University of California, San Francisco
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Three sequential phases: 1. Covert phase: double-blinded (participant, investigator) 2. Overt phase: open-label 3. Withdrawal phase: double-blinded (participant, investigator), randomized, controlled, cross-over withdrawal of seizure forecast
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months. * Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures. * Patients willing and able to keep a diary, issue self-forecasts, and follow instructions. * Home equipped with an internet connection. * Informed Consent signed by the subject
Exclusion criteria
* Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase. * Women pregnant at the time of recruitment (later pregnancy not a contra-indication) * Subjects with a history of psychogenic non-epileptic seizures * Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Vulnerable subjects, including severe cognitive impairment precluding informed consent * Drug or alcohol addiction * Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forecast performance | At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of forecast performance | At least 8 seizures during the overt phase, expected to last 6-12 months | 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. |
| Informativity | Throughout the open-label (6-12 months) and withdrawal phase (3-6 months) | Participant-reported estimates of how informative a forecast is on a visual-analogue scale, scored from 0 to 10. |
| QOLIE-31 | Upon completion of the study after 18-30 months. | 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. |
| Actionability | End of open-label phase after 12-24 months. | List of concrete strategies enabled by the forecasts |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seizure rate | Upon completion of each phase, after 6-12, 12-24 and 18-30 months. | Participant's seizure rate in each phase of the trial expressed as the probability of a seizure per day. |
Countries
United States
Outcome results
None listed