Epilepsy, GeneralizedNCT05477121
Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
An observational study of Epilepsy, Generalized, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy, Generalized
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jun 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Epilepsy, Generalized
- Medical subject headings
- Epilepsy, Generalized
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 4 years
Secondary outcomes (16)
Type of GTCS
According to our previously published classification.
Measured: Through study completion, an average of 4 years
GTCS tonic phase duration on video-EEG recording
In seconds
Measured: Through study completion, an average of 4 years
GTCS clonic phase duration on video-EEG recording
In seconds
Measured: Through study completion, an average of 4 years
Postictal upper limb immobility duration on video-EEG recording
In seconds
Measured: Through study completion, an average of 4 years
Postictal whole-body immobility duration on video-EEG recording
In seconds
Measured: Through study completion, an average of 4 years
Postictal confusion duration on video-EEG recording
In seconds
Measured: Through study completion, an average of 4 years
Postictal bradycardia presence on Electrocardiogram (EKG)
Yes or No
Measured: Through study completion, an average of 4 years
Postictal bradycardia duration on EKG
In seconds
Measured: Through study completion, an average of 4 years
Postictal bradycardia nadir on EKG
Heart rate per minute
Measured: Through study completion, an average of 4 years
Postictal hypoxemia presence on pulse oxymetry
Yes or No
Measured: Through study completion, an average of 4 years
Postictal hypoxemia duration on pulse oxymetry
In seconds
Measured: Through study completion, an average of 4 years
Postictal hypoxemia nadir
Spo2 value in %
Measured: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia presence
Yes or No
Measured: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia duration
In seconds
Measured: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia intensity
Heart rate per minute
Measured: Through study completion, an average of 4 years
Abnormal heart-rate variability during the interictal period
Inter bits per millisecond
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start12 Jun 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Ryvlin, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477121
- Sponsor's protocol ID
- SEVERITY
- Status last verified
- Feb 2025
- First submitted
- 12 Mar 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
- ClinicalTrials.gov ID
- NCT05477121
- Acronym / sponsor ID
- SEVERITY
- Conditions
- Epilepsy, Generalized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
16 secondary outcomes
Type of GTCS
Time frame: Through study completion, an average of 4 years
GTCS tonic phase duration on video-EEG recording
Time frame: Through study completion, an average of 4 years
GTCS clonic phase duration on video-EEG recording
Time frame: Through study completion, an average of 4 years
Postictal upper limb immobility duration on video-EEG recording
Time frame: Through study completion, an average of 4 years
Postictal whole-body immobility duration on video-EEG recording
Time frame: Through study completion, an average of 4 years
Postictal confusion duration on video-EEG recording
Time frame: Through study completion, an average of 4 years
Postictal bradycardia presence on Electrocardiogram (EKG)
Time frame: Through study completion, an average of 4 years
Postictal bradycardia duration on EKG
Time frame: Through study completion, an average of 4 years
Postictal bradycardia nadir on EKG
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia presence on pulse oxymetry
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia duration on pulse oxymetry
Time frame: Through study completion, an average of 4 years
Postictal hypoxemia nadir
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia presence
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia duration
Time frame: Through study completion, an average of 4 years
Peri-ictal tachycardia or bradycardia intensity
Time frame: Through study completion, an average of 4 years
Abnormal heart-rate variability during the interictal period
Time frame: Through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Generalized, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of PGES (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.