Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) with Connected Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- duration of PGES
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
duration of PGES
时间窗: 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.
次要结局
- Type of GTCS(Through study completion, an average of 4 years)
- GTCS tonic phase duration on video-EEG recording(Through study completion, an average of 4 years)
- Postictal upper limb immobility duration on video-EEG recording(Through study completion, an average of 4 years)
- Postictal bradycardia duration on EKG(Through study completion, an average of 4 years)
- Postictal whole-body immobility duration on video-EEG recording(Through study completion, an average of 4 years)
- Postictal bradycardia presence on Electrocardiogram (EKG)(Through study completion, an average of 4 years)
- Postictal hypoxemia presence on pulse oxymetry(Through study completion, an average of 4 years)
- Postictal hypoxemia duration on pulse oxymetry(Through study completion, an average of 4 years)
- Postictal confusion duration on video-EEG recording(Through study completion, an average of 4 years)
- Postictal hypoxemia nadir(Through study completion, an average of 4 years)
- Peri-ictal tachycardia or bradycardia presence(Through study completion, an average of 4 years)
- Peri-ictal tachycardia or bradycardia duration(Through study completion, an average of 4 years)
- Abnormal heart-rate variability during the interictal period(Through study completion, an average of 4 years)
- GTCS clonic phase duration on video-EEG recording(Through study completion, an average of 4 years)
- Postictal bradycardia nadir on EKG(Through study completion, an average of 4 years)
- Peri-ictal tachycardia or bradycardia intensity(Through study completion, an average of 4 years)
研究者
Philippe Ryvlin
Professor, head of the department of clinical neurosciences, principal investigator
Centre Hospitalier Universitaire Vaudois