Severity: Quantifying the Severity of Generalized Tonic-c... | NCT05477121

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

NCT05477121

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Feb 18, 2025Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Epilepsy, Generalized

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Mar 12, 2022

First Submission Date that Met QC Criteria

Jul 26, 2022

First Posted Date

Jul 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2025

Last Update Posted Date

Feb 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Type of GTCS	According to our previously published classification.	Through study completion, an average of 4 years
GTCS tonic phase duration on video-EEG recording	In seconds

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
NeuroDigital@NeuroTech		Lausanne		1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases