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

Epilepsy, Generalized Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477121
• Other study ID #: SEVERITY
• Status: Recruiting
• Start date: June 12, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: philippe Ryvlin, Prof
• Phone: 021 314 12 35
• Email: philippe.ryvlin[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy, Generalized
• Seizures

Locations

Country	Name	City	State
Switzerland	Neurotech	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type of GTCS	According to our previously published classification.	Through study completion, an average of 4 years
Secondary	GTCS tonic phase duration on video-EEG recording	In seconds	Through study completion, an average of 4 years
Secondary	GTCS clonic phase duration on video-EEG recording	In seconds	Through study completion, an average of 4 years
Secondary	Postictal upper limb immobility duration on video-EEG recording	In seconds	Through study completion, an average of 4 years
Secondary	Postictal whole-body immobility duration on video-EEG recording	In seconds	Through study completion, an average of 4 years
Secondary	Postictal confusion duration on video-EEG recording	In seconds	Through study completion, an average of 4 years
Secondary	Postictal bradycardia presence on Electrocardiogram (EKG)	Yes or No	Through study completion, an average of 4 years
Secondary	Postictal bradycardia duration on EKG	In seconds	Through study completion, an average of 4 years
Secondary	Postictal bradycardia nadir on EKG	Heart rate per minute	Through study completion, an average of 4 years
Secondary	Postictal hypoxemia presence on pulse oxymetry	Yes or No	Through study completion, an average of 4 years
Secondary	Postictal hypoxemia duration on pulse oxymetry	In seconds	Through study completion, an average of 4 years
Secondary	Postictal hypoxemia nadir	Spo2 value in %	Through study completion, an average of 4 years
Secondary	Peri-ictal tachycardia or bradycardia presence	Yes or No	Through study completion, an average of 4 years
Secondary	Peri-ictal tachycardia or bradycardia duration	In seconds	Through study completion, an average of 4 years
Secondary	Peri-ictal tachycardia or bradycardia intensity	Heart rate per minute	Through study completion, an average of 4 years
Secondary	Abnormal heart-rate variability during the interictal period	Inter bits per millisecond	Through study completion, an average of 4 years