Optimization of Physical Focal Stimulation Parameters for Improving Spasticity and Identification of Neurophysiological Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- H/M ratio
研究概览
简要总结
The overall aim of the proposed study is to determine optimal parameter of focal muscle vibration for improving spasticity and identify neurophysiological mechanism in healthy subjects.
In investigation I-1, subjects will undergo focal muscle vibration with 40, 80, 120 Hz frequency at the medial gastrocnemius muscles (mGCM). As a surrogate maker of spasticity, H-reflex and compound motor action potential (CMAP) of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
In investigation I-2, subjects will undergo focal muscle vibration with 0.1, 0.3, 0.5 mm amplitude at mGCM. H-reflex and CMAP of the tibial nerve at mGCM will be recorded pre, during, and post vibration.
In investigation II, subjects will undergo focal muscle vibration with predetermined parameters by the investigation I at mGCM. H-reflex and CMAP of the tibial nerve and motor evoked potential at mGCM will be recorded pre, during, and post vibration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
排除标准
- •Unstable medical conditions
- •History of epilepsy
- •History of drug abuse
结局指标
主要结局
H/M ratio
时间窗: baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration
The ratio of maximal H-reflex amplitude (mV) to CMAP amplitude (mV) recorded at mGCM
次要结局
- M amplitude(baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration)
- motor evoked potential (MEP) amplitude(baseline, 10 minutes during vibration, and 5 minutes after vibration)
- H amplitude(baseline, 1, 5 and 10 minutes during vibration, and 1 and 5 minutes after vibration)
- Resting motor threshold (RMT)(baseline, 10 minutes during vibration, and 5 minutes after vibration)
- Short interval intracortical inhibition(baseline, 10 minutes during vibration, and 5 minutes after vibration)
- Intracortical facilitation(baseline, 10 minutes during vibration, and 5 minutes after vibration)
研究者
Byung-Mo Oh
Department of Rehabilitation Medicine
Seoul National University Hospital