Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Pain reduction measured by Pain Questionnaire
研究概览
简要总结
NI-ES therapy is a treatment that is being studied to potentially treat pain associated with SCI and may help movement below the injury site.
详细描述
The overall goal of this study is to assess the use of externally applied micro-current electrical stimulation in a subject with SCI to reduce pain and patient perceived improvement of quality of life first, and second, movement below the SCI injury. The Hypothesis is that NI-ES is beneficial in reducing pain following SCI injury, patient perceived quality of life measures, and functional outcomes. We plan to achieve this goal by conducting a Pain Questionnaire and assessment of movement below the injury site prior to external micro-current electrical stimulation with the Spinal Stim (Alpha-Stim M with the Ocular Interface and the Spinal Interface) and again six weeks following the first treatment. These results will be used to characterize the extent and duration of any improvement in pain and movement as a result of treatment with the Spinal Stim.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •The presence of SCI
- •Pain associated with the SCI
- •Difficulty with body movement below the SCI
排除标准
- •Absence of SCI
- •Poor health
- •Deemed unsuitable for participation by the Investigator.
结局指标
主要结局
Pain reduction measured by Pain Questionnaire
时间窗: 6 weeks
Reduce neuropathic pain
次要结局
- Functional movement as measured by the ASIA Motor Score(6 weeks)