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

NCT06952764 | Enrolling By Invitation

• 1 other identifier: 2025 - SWEZ01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Epilepsy (Treatment Refractory)

Keywords

Seizure forecasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Maintenance of forecast performance

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

• Informativity

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

• QOLIE-31

  Upon completion of the study after 18-30 months.

• Actionability

  End of open-label phase after 12-24 months.

Other Outcomes (1)

• Seizure rate

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

Study Arms (2)

IEEG-forecast

EXPERIMENTAL

Potentially informative seizure forecast.

Other: Seizure risk forecast

Control-forecast

ACTIVE COMPARATOR

Uninformative control seizure forecast.

Other: Control seizure risk forecast

Interventions

Seizure risk forecast OTHER

Participants are provided with daily risk estimates about upcoming seizure likelihood.

IEEG-forecast

Control seizure risk forecast OTHER

Participant receive uninformative control forecast

Control-forecast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maxime O Baud, MD, PhD

  Department of Neurology, Inselspital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three sequential phases: 1. Covert phase: double-blinded (participant, investigator) 2. Overt phase: open-label 3. Withdrawal phase: double-blinded (participant, investigator), randomized, controlled, cross-over withdrawal of seizure forecast

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be shared 2-4 years after study start and up to a duration of 10 years.
• Access Criteria: Researcher will be able to access the data.

Locations

US (1)