NCT06952764Enrolling by invitation
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.
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Epilepsy
- NCT number
- NCT06952764
What you commit to
- Study type: Interventional
- Planned participants: 14
- From 1 May 2025 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Drug or alcohol addiction
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.