Seizure Risk Forecasting for Epilepsy
(ECLIPSE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment 'Control seizure risk forecast, Seizure risk forecast' for epilepsy?
Research shows that seizure forecasting using wearable devices and algorithms can predict seizure risk, potentially reducing injuries and deaths. These forecasts have been validated in studies, showing promising results in predicting seizure likelihood and clusters, which could help manage epilepsy more effectively.12345
Is the seizure risk forecasting treatment safe for humans?
The research articles primarily discuss the safety of antiepileptic drugs (AEDs) in general, noting that adverse drug reactions (ADRs) are common but can decrease with monitoring. While these studies focus on AEDs, they highlight the importance of monitoring for safety in treatments related to epilepsy.678910
How does the seizure risk forecasting treatment differ from other epilepsy treatments?
The seizure risk forecasting treatment is unique because it uses non-invasive wearable devices to predict the likelihood of seizures by analyzing cycles of epileptic activity, heart rate, and other physiological signals. This approach aims to provide continuous, probabilistic forecasts of seizure risk, which can help patients and clinicians better manage epilepsy by anticipating and potentially preventing seizures.2341112
What is the purpose of this trial?
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.
Research Team
Maxime O Baud, MD, PhD
Principal Investigator
Department of Neurology, Inselspital Bern
Eligibility Criteria
This trial is for adults with hard-to-treat epilepsy who've had at least one seizure in the past year. They must have internet at home, a specific brain activity monitoring device already implanted, and be able to keep a diary of seizures. People can't join if they have drug or alcohol addiction, are pregnant, have certain other health problems, or can't use the monitoring device properly.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Covert Phase
Participants receive double-blinded IEEG forecasts to evaluate performance against electrographic seizures
Overt Phase
Participants receive open-label forecasts to assess informativity and actionability
Withdrawal Phase
Participants experience a withdrawal of forecast information to assess changes in seizure management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Control seizure risk forecast
- Seizure risk forecast
Find a Clinic Near You
Who Is Running the Clinical Trial?
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
University of California, San Francisco
Collaborator