Trials / Completed
CompletedNCT05477121
Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (actual)
- Sponsor
- Centre Hospitalier Universitaire Vaudois · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2019-06-12
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2022-07-28
- Last updated
- 2025-02-18
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05477121. Inclusion in this directory is not an endorsement.