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NCT06952764

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

Enrolling by Invitation
NAAges 18+InterventionalSupportive care
Insel Gruppe AG, University Hospital Bern
~14 participants
Updated 2025-05-01 on ClinicalTrials.gov
What's tested:Seizure risk forecastControl seizure risk forecast

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Forecast performance
Measured over At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.

Conditions

Epilepsy (Treatment Refractory)

Explore related trials

Seizure Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Maxime O Baud, MD, PhD · STUDY_CHAIR · Department of Neurology, Inselspital Bern

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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.

What this trial measures

  • Forecast performanceAt least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.

    Performance of double-blinded (covert phase) IEEG-forecasts. Performance is quantified as the area-under-the sensitivity vs. time in warning curve (AUC) and double-tested statistically in a pairwise manner against shuffled chance-forecasts and participant's self-forecasts.