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Enrolling by Invitation

NCT Number: NCT06952764

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

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.

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Key information

Conditions

Epilepsy (treatment Refractory) Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Forecast performance

    Time frame: At 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.

Secondary outcomes

  1. Maintenance of forecast performance

    Time frame: At least 8 seizures during the overt phase, expected to last 6-12 months

    For the cohort that progresses to the overt phase, The AUC obtained during the overt phase will be compared to their historical AUC during the covert phase and tested for a pairwise difference.

  2. Informativity

    Time frame: Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)

    Participant-reported estimates of how informative a forecast is on a visual-analogue scale, scored from 0 to 10.

  3. QOLIE-31

    Time frame: Upon completion of the study after 18-30 months.

    Quality Of Life In Epilepsy questionnaires with 31 items (QOLIE-31) completed at the transition from one study phase to the next. The quantification is on a scale from 0 to 100 and pairwise comparison between covert, overt and withdrawal phase.

  4. Actionability

    Time frame: End of open-label phase after 12-24 months.

    List of concrete strategies enabled by the forecasts

Other outcomes

  1. Seizure rate

    Time frame: Upon completion of each phase, after 6-12, 12-24 and 18-30 months.

    Participant's seizure rate in each phase of the trial expressed as the probability of a seizure per day.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study 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.

Acronym: ECLIPSE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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