This study is accepting new patients by invitation only

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

a study on Epilepsy Seizures

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official 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.

Keywords

Epilepsy (Treatment Refractory), Seizure forecasting, Epilepsy, Seizures, Seizure risk forecast, IEEG-forecast

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

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

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern
ID
NCT06952764
Study Type
Interventional
Participants
Expecting 14 study participants
Last Updated