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

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy (Treatment Refractory)
• Intervention / Treatment: Other: Seizure risk forecast; Other: Control seizure risk forecast

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IEEG-forecast; Potentially informative seizure forecast.	Other: Seizure risk forecast; Participants are provided with daily risk estimates about upcoming seizure likelihood.
Active Comparator: Control-forecast; Uninformative control seizure forecast.	Other: Control seizure risk forecast; Participant receive uninformative control forecast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forecast performance	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.	At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of forecast performance	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.	At least 8 seizures during the overt phase, expected to last 6-12 months
Informativity	Participant-reported estimates of how informative a forecast is on a visual-analogue scale, scored from 0 to 10.	Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)
QOLIE-31	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.	Upon completion of the study after 18-30 months.
Actionability	List of concrete strategies enabled by the forecasts	End of open-label phase after 12-24 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure rate	Participant's seizure rate in each phase of the trial expressed as the probability of a seizure per day.	Upon completion of each phase, after 6-12, 12-24 and 18-30 months.

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: University of California, San Francisco
• Investigators: Study Chair: Maxime O Baud, MD, PhD, Department of Neurology, Inselspital Bern

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Seizure forecasting
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Seizures
• Other Study ID Numbers: 2025 - SWEZ01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data can be shared by the investigators upon study completion based on a reasonable request.
• IPD Sharing Time Frame: The data will be shared 2-4 years after study start and up to a duration of 10 years.
• IPD Sharing Access Criteria: Researcher will be able to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No