Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Freezing of gait score
研究概览
简要总结
Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn.
详细描述
Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn. In this pilot trial, the investigators recruit participants with Parkinson' disease and freezing of gait. The aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •diagnosis of advanced idiopathic Parkinson's disease
- •significant freezing of gait despite optimized treatment with medications and rehabilitation program
排除标准
- •psychiatric symptoms
- •cardiac pacemaker
结局指标
主要结局
Freezing of gait score
时间窗: One week
The primary outcome is the freezing of gait score. 12-item scale, each item scores 3 points at maximum; the score ranges from 0-36; higher scores mean higher severity
次要结局
- Gait speed(baseline, 1 week, 4 week)
- Freezing of gait questionnaire(baseline, 1 week, 4 week)
- Safety of the intervention - urinary incontinence(1 week, 4 week)
- Safety of the intervention - lower limb strength.(1 week, 4 week)
研究者
Rubens Gisbert Cury
Principal investigator
University of Sao Paulo General Hospital