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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Epilepsy, Generalized

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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