NCT04486209已完成早期 1 期
Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve spasticity and residual motor control in the same subject population. The present study explores whether single sessions of noninvasive SCS would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS
- •lower-limb spasticity
排除标准
- •acute relapse of MS
- •other neuromuscular diseases
- •active and passive implants at vertebral level T9 or caudally
- •dermatological issues at stimulation site
- •pregnancy
结局指标
主要结局
Modified Ashworth Scale
时间窗: 24 hours
次要结局
- Timed up an go test(24 hours)
- 2-min walk test(24 hours)
- 10-m walk test(24 hours)
研究者
Ursula Hofstoetter
Senior researcher
Medical University of Vienna
研究点 (2)
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