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临床试验/NCT04486209
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

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年12月27日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ursula Hofstoetter

Senior researcher

Medical University of Vienna

研究点 (2)

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