NCT02313194进行中（未招募）1 期
Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of arm/hand function
研究概览
简要总结
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.
详细描述
An epidural stimulation device will be tested to determine if motor function can be improved.
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
- •Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
- •No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
- •No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
- •No clinically significant depression or ongoing drug abuse
- •No current anti-spasticity medication regimen
- •Non-progressive SCI above C5
- •Must not have received botox injections in the prior six months
- •Be unable to grip or move independently
- •Be at least one-year post injury
- •Must be at least 18 years of age
- •Segmental reflexes remain functional below the lesion
- •Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
- •No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
- •No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
- •Must not be involved in another clinical trial
- •Must not have disorders or conditions that would require MRI monitoring
排除标准
- •None as long as inclusion criteria are met.
研究组 & 干预措施
Stimulation
Experimental
Determine if epidural stimulation can improve motor function.
干预措施: Epidural Stimulation (Device)
Stimulation
Experimental
Determine if epidural stimulation can improve motor function.
干预措施: Buspirone (Drug)
结局指标
主要结局
Assessment of arm/hand function
时间窗: 24 months
Formal motor testing
次要结局
未报告次要终点
研究者
Daniel Lu, MD, PhD
Associate Professor
University of California, Los Angeles
研究点 (1)
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