An observational study in Epilepsy, Generalized, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Centre Hospitalier Universitaire Vaudois · Observational
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.
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).
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's enrollment of 400 is above the median of 80 across 13 observational studies indexed under Epilepsy, Generalized.
Browse Epilepsy, Generalized studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: Through study completion, an average of 4 years
Type of GTCS
According to our previously published classification.
Time frame: Through study completion, an average of 4 years
GTCS tonic phase duration on video-EEG recording
In seconds
Time frame: Through study completion, an average of 4 years
GTCS clonic phase duration on video-EEG recording
In seconds
Time frame: Through study completion, an average of 4 years
Postictal upper limb immobility duration on video-EEG recording
In seconds
Time frame: Through study completion, an average of 4 years
Postictal whole-body immobility duration on video-EEG recording
In seconds
Time frame: Through study completion, an average of 4 years
Postictal confusion duration on video-EEG recording
In seconds
Time frame: Through study completion, an average of 4 years
Postictal bradycardia presence on Electrocardiogram (EKG)
Yes or No
Time frame: Through study completion, an average of 4 years
Postictal bradycardia duration on EKG
In seconds
Time frame: Through study completion, an average of 4 years
Postictal bradycardia nadir on EKG
Heart rate per minute
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia presence on pulse oxymetry
Yes or No
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia duration on pulse oxymetry
In seconds
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia nadir
Spo2 value in %
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia presence
Yes or No
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia duration
In seconds
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia intensity
Heart rate per minute
Time frame: Through study completion, an average of 4 years
Abnormal heart-rate variability during the interictal period
Inter bits per millisecond
Time frame: Through study completion, an average of 4 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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