Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

Part of paid clinical trials in San Francisco, California.

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06952764
Status
Enrolling By Invitation

Conditions

  • Epilepsy (Treatment Refractory)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Seizure risk forecast — OTHER
    Participants are provided with daily risk estimates about upcoming seizure likelihood.
  • Control seizure risk forecast — OTHER
    Participant receive uninformative control forecast

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: IEEG-forecast
    Potentially informative seizure forecast.
  • Active Comparator: Control-forecast
    Uninformative control seizure forecast.

Primary Outcome Measure

Forecast performance [ Time Frame: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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By research site
University of California, San Francisco· San Francisco, CA

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