NCT06952764

Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation, A Double-blinded Study of Seizure Forecasting and Randomized Information Withdrawal in Adults With Epilepsy.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy (Treatment Refractory)

Interventions

Type	Name	Description
OTHER	Seizure risk forecast	Participants are provided with daily risk estimates about upcoming seizure likelihood.
OTHER	Control seizure risk forecast	Participant receive uninformative control forecast

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-04-30
• Completion: 2028-12-31
• First posted: 2025-05-01
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States