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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Epilepsy (Treatment Refractory)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IEEG-forecast

Potentially informative seizure forecast.

Group Type EXPERIMENTAL

Seizure risk forecast

Intervention Type OTHER

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

Control-forecast

Uninformative control seizure forecast.

Group Type ACTIVE_COMPARATOR

Control seizure risk forecast

Intervention Type OTHER

Participant receive uninformative control forecast

Interventions

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Seizure risk forecast

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

Intervention Type OTHER

Control seizure risk forecast

Participant receive uninformative control forecast

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No