G40
Conditions
Interventions
Group 1: This study will take place during routine clinical evaluations at in-hospital epilepsy centers. During the evaluation, VEEG, EKG, and pulse oximetry, will be continuously recorded under perma
Sponsors
Centre Hospitalier Universitaire Vaudois Lausanne
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: - Male or female aged 12 years or older, suffering from epilepsy - Patient undergoing VEEG recording - Patient at risk of presenting a GTCS during VEEG monitoring according to one of the following criteria (i) known to suffer from GTCS, or (ii) considered for AED tapering during VEEG (GTCS often occurred during VEEG 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
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 as risk of presenting a GTCS during VEEG because they are not known to suffer GTCS and not candidate to AED tapering during VEEG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the duration of PGES, as defined by a postictal EEG flattening <10 microV over all scalp-EEG leads. 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
| Measure | Time frame |
|---|---|
| - Other dependent variables reflecting GTCS severity routinely captured during video-EEG o The type of GTCS (according to our previously published classification). o The duration of the tonic phase of GTCS as observed on video-EEG recording o The duration of the clonic phase of GTCS as observed on video-EEG recording - The duration of postictal upper limb immobility as observed on video-EEG recording - The duration of postictal whole-body immobility as observed on video-EEG recording - The duration of the postictal confusion as observed on video-EEG recording - The presence, duration, and nadir of postictal bradycardia as observed on EKG - The presence, duration, and nadir of postictal hypoxemia as observed on pulse oximetry - All adverse events occurring during the study, including those potentially related to sensors | — |
Countries
Austria, Denmark, France, Germany, Switzerland
Contacts
Public ContactPhilippe Ryvlin
Département des Neurosciences CliniquesCentre Hospitalier Universitaire Vaudois (CHUV)BH/10/137
Outcome results
None listed