NCT05627661已完成不适用
Managing Multiple Seizure Types With Wearable Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of high-quality physiological signals
研究概览
简要总结
The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with or suspected of having autoimmune epilepsy.
- •Normal controls - cognitively normal subjects without epilepsy
排除标准
- •Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).
结局指标
主要结局
Number of high-quality physiological signals
时间窗: 10 days
Total number of high-quality physiological signals recorded by biosensors
Number of Reproducible changes in physiological biosignals
时间窗: 10 days
Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures
次要结局
未报告次要终点
研究者
Benjamin H. Brinkmann
Principal Investigator
Mayo Clinic
研究点 (2)
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