Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Seizure risk forecast, Control seizure risk forecast.
- Who it may be relevant to
- Registry conditions: Epilepsy (Treatment Refractory). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Forecast performance [Time frame: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.]
Secondary outcome measures (4)
- Maintenance of forecast performance [Time frame: At least 8 seizures during the overt phase, expected to last 6-12 months]
- Informativity [Time frame: Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)]
- QOLIE-31 [Time frame: Upon completion of the study after 18-30 months.]
- Actionability [Time frame: End of open-label phase after 12-24 months.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06952764 · 2025 - SWEZ01