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Completed

NCT Number: NCT05477121

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

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.

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Key information

Conditions

Epilepsy, Generalized Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NeuroDigital@NeuroTech

Lausanne, 1011, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. duration of PGES

    Time frame: 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 outcomes

  1. Type of GTCS

    Time frame: Through study completion, an average of 4 years

    According to our previously published classification.

  2. GTCS tonic phase duration on video-EEG recording

    Time frame: Through study completion, an average of 4 years

    In seconds

  3. GTCS clonic phase duration on video-EEG recording

    Time frame: Through study completion, an average of 4 years

    In seconds

  4. Postictal upper limb immobility duration on video-EEG recording

    Time frame: Through study completion, an average of 4 years

    In seconds

  5. Postictal whole-body immobility duration on video-EEG recording

    Time frame: Through study completion, an average of 4 years

    In seconds

  6. Postictal confusion duration on video-EEG recording

    Time frame: Through study completion, an average of 4 years

    In seconds

  7. Postictal bradycardia presence on Electrocardiogram (EKG)

    Time frame: Through study completion, an average of 4 years

    Yes or No

  8. Postictal bradycardia duration on EKG

    Time frame: Through study completion, an average of 4 years

    In seconds

  9. Postictal bradycardia nadir on EKG

    Time frame: Through study completion, an average of 4 years

    Heart rate per minute

  10. Postictal hypoxemia presence on pulse oxymetry

    Time frame: Through study completion, an average of 4 years

    Yes or No

  11. Postictal hypoxemia duration on pulse oxymetry

    Time frame: Through study completion, an average of 4 years

    In seconds

  12. Postictal hypoxemia nadir

    Time frame: Through study completion, an average of 4 years

    Spo2 value in %

  13. Peri-ictal tachycardia or bradycardia presence

    Time frame: Through study completion, an average of 4 years

    Yes or No

  14. Peri-ictal tachycardia or bradycardia duration

    Time frame: Through study completion, an average of 4 years

    In seconds

  15. Peri-ictal tachycardia or bradycardia intensity

    Time frame: Through study completion, an average of 4 years

    Heart rate per minute

  16. Abnormal heart-rate variability during the interictal period

    Time frame: Through study completion, an average of 4 years

    Inter bits per millisecond

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jul 28, 2022
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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