Clinical trial NCT05477121: Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
Official title: Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Generalized
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: duration of PGES
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Type of GTCS
timeFrame: Through study completion, an average of 4 years
measure: GTCS tonic phase duration on video-EEG recording
timeFrame: Through study completion, an average of 4 years
measure: GTCS clonic phase duration on video-EEG recording
timeFrame: Through study completion, an average of 4 years
measure: Postictal upper limb immobility duration on video-EEG recording
timeFrame: Through study completion, an average of 4 years
measure: Postictal whole-body immobility duration on video-EEG recording
timeFrame: Through study completion, an average of 4 years
measure: Postictal confusion duration on video-EEG recording
timeFrame: Through study completion, an average of 4 years
measure: Postictal bradycardia presence on Electrocardiogram (EKG)
timeFrame: Through study completion, an average of 4 years
measure: Postictal bradycardia duration on EKG
timeFrame: Through study completion, an average of 4 years
measure: Postictal bradycardia nadir on EKG
timeFrame: Through study completion, an average of 4 years
measure: Postictal hypoxemia presence on pulse oxymetry
timeFrame: Through study completion, an average of 4 years
measure: Postictal hypoxemia duration on pulse oxymetry
timeFrame: Through study completion, an average of 4 years
measure: Postictal hypoxemia nadir
timeFrame: Through study completion, an average of 4 years
measure: Peri-ictal tachycardia or bradycardia presence
timeFrame: Through study completion, an average of 4 years
measure: Peri-ictal tachycardia or bradycardia duration
timeFrame: Through study completion, an average of 4 years
measure: Peri-ictal tachycardia or bradycardia intensity
timeFrame: Through study completion, an average of 4 years
measure: Abnormal heart-rate variability during the interictal period
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: NeuroDigital@NeuroTech
Study officials:
References: