Status:
ENROLLING_BY_INVITATION
Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Epilepsy (Treatment Refractory)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06952764
Start Date
May 1 2025
End Date
December 31 2028
Last Update
May 1 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143