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

Last updated: February 14, 2025
Sponsor: Centre Hospitalier Universitaire Vaudois
Overall Status: Completed

Phase

N/A

Condition

Seizure Disorders

Treatment

N/A

Clinical Study ID

NCT05477121
SEVERITY
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe following criteria (i) known to suffer from GTCS, or (ii) considered forAntiepileptic drugs (AED) tapering during Video-EEG (GTCS often occur duringVideo-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 patientor legal representative when required.

Exclusion

Exclusion Criteria:

  • Patients aged less than 12 years old

  • Patient not willing to participate in the study, and where informed consent from thepatient or the legal representative, when required, cannot be obtained - Patientconsidered not at risk of presenting a GTCS during Video-EEG because they are notknown to suffer GTCS and not candidate to AED tapering during Video-EEG.

Study Design

Total Participants: 400
Study Start date:
June 12, 2019
Estimated Completion Date:
December 31, 2024

Study 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).

Connect with a study center

  • NeuroDigital@NeuroTech

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Neurotech

    Lausanne, 1011
    Switzerland

    Active - Recruiting

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