Clinical trial NCT06952764: Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy (Treatment Refractory)
Keywords: Seizure forecasting
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2025-05-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Forecast performance
timeFrame: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.
Secondary outcomes:
measure: Maintenance of forecast performance
timeFrame: At least 8 seizures during the overt phase, expected to last 6-12 months
measure: Informativity
timeFrame: Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)
measure: QOLIE-31
timeFrame: Upon completion of the study after 18-30 months.
measure: Actionability
timeFrame: End of open-label phase after 12-24 months.
Other outcomes:
measure: Seizure rate
timeFrame: Upon completion of each phase, after 6-12, 12-24 and 18-30 months.
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Department of Neurology, Inselspital Bern
name: Maxime O Baud, MD, PhD
role: STUDY_CHAIR
References: