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

Vaud University Hospital Center

Status: Completed

Conditions: Epilepsy, Generalized

Study type: Observational

Funder types: Other

Identifiers

NCT05477121

SEVERITY

Details and patient eligibility

About

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.

Full 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).

Enrollment: 400 patients

Sex: All

Ages: 12+ years old

Volunteers: No 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.