Tests daily seizure-risk forecasts for adults with hard-to-treat epilepsy
Tests daily seizure-risk forecasts in adults with treatment-resistant epilepsy.
Plain-language title generated from the registry record
Registry title: Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
Key facts
- Where
- San Francisco, United StatesSee the site
Where in United States
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT06952764
- Record updated
- 1 May 2025
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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: Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.); Drug or alcohol addiction; Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase; Subjects with a history of psychogenic non-epileptic seizures; Vulnerable subjects, including severe cognitive impairment precluding informed consent; Women pregnant at the time of recruitment (later pregnancy not a contra-indication); Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.