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Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices | Clinical Trials | Clareo Health

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Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices

NCT05477121•Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

Summary

By bringing together the fields of seizure detection and that of Sudden Unexpected Death in Epilepsy (SUDEP), the current project aims at delineating which set of biosensors and related biomarkers would optimally characterize the severity of GTCS and the associated risk of SUDEP.

Detailed Description

The main objective is to to evaluate which of the five biosignals considered, being, electrodermal activity (EDA), heart rate (HR), accelerometry (AC), arm-measurement of skin electromyography (EMG), and bed sensing of body movement (BM), or any of their combinations, offers the most accurate detection and quantification of our primary indicator of GTCS-severity, i.e. postictal EEG suppression (PGES).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female aged 12 years or older, suffering from epilepsy
•Patient undergoing Video-EEG recording
•Patient at risk of presenting a GTCS during Video-EEG monitoring according to one of the following criteria (i) known to suffer from GTCS, or (ii) considered for Antiepileptic drugs (AED) tapering during Video-EEG (GTCS often occur during Video-EEG as a result of AED tapering for promoting the occurrence of seizures).
•Patient willing to participate in the study and signed informed consent, by patient or legal representative when required.

Exclusion Criteria

•Patients aged less than 12 years old
•Patient not willing to participate in the study, and where informed consent from the patient or the legal representative, when required, cannot be obtained - Patient considered not at risk of presenting a GTCS during Video-EEG because they are not known to suffer GTCS and not candidate to AED tapering during Video-EEG.

Locations (1)

NeuroDigital@NeuroTech

Lausanne, Switzerland

Key Dates

Start Date

June 12, 2019

Primary Completion Date

December 31, 2023

Completion Date

December 31, 2024

Last Updated

February 18, 2025

Enrollment

400

ACTUAL participants

Conditions

Epilepsy, Generalized

Exercise for Memory Rehabilitation in Epilepsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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