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

NCT ID: NCT05477121

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2024-12-31

Brief 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).

Conditions

Epilepsy, Generalized

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Philippe Ryvlin

Professor, head of the department of clinical neurosciences, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NeuroDigital@NeuroTech

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

SEVERITY

Identifier Type: -

Identifier Source: org_study_id