Formative Validation of the MoveChecker System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- motion sequences of at least 60 epileptic seizures
研究概览
简要总结
obtain motion sequences of at least 60 epileptic seizures
详细描述
Extensive movement data are required to develop an automatic pattern recognition that makes it possible to distinguish movements of epileptic seizures from everyday activities. The aim of collecting formative validation data for the system is to collect movement data from as many epileptic seizures as possible to develop such pattern recognition in the future.
A system is being investigated that uses several non-invasive sensors attached to the extremities and trunk of the test subjects with plasters to record abnormal movement patterns and play them back to detect epileptic seizures with motor involvement. In the study registered here, the movement data of at least 60 epileptic seizures with motor components will be recorded parallel to routine diagnostics using video EEG or video monitoring.
The primary goal is to collect formative validation data for the system. This includes recording the movements of at least 60 epileptic seizures per sample during the hospital stay of the participants to develop future pattern recognition for the system. The secondary goals include the qualitative assessment of the clinical benefit of the system from the point of view of the patient and the medical staff.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •diagnosis of epilepsy (ICD code G40.x)
排除标准
- •suspected epilepsy (no diagnosis)
- •comorbidities affecting the motor system
- •dermatosis in an area of the body relevant to the sensor attachment
- •contact allergy due to plaster or sensor material
- •known or current illness or disorder that interferes with the ability to understand study participation requirements or to provide informed consent
结局指标
主要结局
motion sequences of at least 60 epileptic seizures
时间窗: up to 4 days
Motion sequences of at least 60 epileptic seizures, that include the spatial orientation of the nine sensors attached to the participant sampled and recorded at a rate of 30Hz continuously
次要结局
- qualitative assessment of the clinical benefit of the system(through study completion)