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

• Conditions: Epilepsy, Generalized

• Registration Number: NCT05477121
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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).

Study Timeline

• Study Start: 2019-06-12
• Study First Submitted: 2022-03-12
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of PGES	Through study completion, an average of 4 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Neurotech; 🇨🇭 Lausanne, Switzerland