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

NCT05477121 | Completed

• 1 other identifier: SEVERITY
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Generalized

Outcome Measures

Primary Outcomes (1)

• duration of PGES

  The primary endpoint of the study is the duration of PGES, as defined by a postictal EEG flattening \<10microvolt over all scalp-EEG leads (time in seconds). When no PGES is observed, the duration will be coded as 0. This will be used as a dependent variable in the primary analysis.

  Through study completion, an average of 4 years

Secondary Outcomes (16)

• Type of GTCS

  Through study completion, an average of 4 years

• GTCS tonic phase duration on video-EEG recording

  Through study completion, an average of 4 years

• GTCS clonic phase duration on video-EEG recording

  Through study completion, an average of 4 years

• Postictal upper limb immobility duration on video-EEG recording

  Through study completion, an average of 4 years

• Postictal whole-body immobility duration on video-EEG recording

  Through study completion, an average of 4 years

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A cohort of 500 patients with active epilepsy, undergoing Video-EEG monitoring in one of the participating epilepsy centers will be enrolled in this study with the aim to record epileptic seizures for routine clinical, and not primarily research objectives (e.g. presurgical evaluation, other diagnostic purposes). The project population will be composed of adult patients who give informed consent independently as well as of children, and adult patients who lack the capacity to consent to matters concerning their personal health care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

NeuroDigital@NeuroTech

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Epilepsy, Generalized

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of the department of clinical neurosciences, principal investigator

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: July 28, 2022
• Study Start: June 12, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CH (1)