跳至主要内容
临床试验/NCT03148106
NCT03148106
进行中(未招募)
不适用

Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 25 人2017年4月4日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Upper Extremity Paresis
发起方
University of California, San Francisco
入组人数
25
试验地点
1
主要终点
Change in Finger Fractionation
状态
进行中(未招募)
最后更新
11个月前

概览

简要总结

The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.

注册库
clinicaltrials.gov
开始日期
2017年4月4日
结束日期
2028年12月1日
最后更新
11个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.

排除标准

  • Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score \>3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a pacemaker.

结局指标

主要结局

Change in Finger Fractionation

时间窗: Baseline and immediately post-stimulation

Ability to fractionate movement can be assessed by asking the patient to move one segment in isolation and keep other, adjacent segments still.

次要结局

  • Change in Arm Research Action Test(Baseline and immediately post-stimulation)
  • Change in Modified Ashworth Scale(Baseline and immediately post-stimulation)

研究点 (1)

Loading locations...

相似试验