Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Efficacy of epidural SCS
研究概览
简要总结
The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).
详细描述
For people with cervical spinal cord injury (SCI), regaining hand and arm function is their highest priority. Epidural stimulation enables recovery of walking and autonomic function in people with chronic SCI, but how the spinal cord should be stimulated to restore arm and hand function is not known. This project seeks to advance our understanding of how best to apply epidural electrical stimulation (EES) after cervical SCI using complementary experiments in humans and rats. This improved understanding will be used to conduct a preclinical study of the efficacy of different sites of cervical spinal cord stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Clinical indication for cervical spine surgery.
排除标准
- •Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
结局指标
主要结局
Efficacy of epidural SCS
时间窗: 0-100 milliseconds after each stimulation event during the experiment
Efficacy of stimulation is calculated as 1/threshold for provoking an motor evoked potentials. The threshold will be calculated from the recruitment curves.
Selectivity of epidural SCS
时间窗: 0-100 milliseconds after each stimulation event during the experiment
Selectivity is calculated from the recruitment curves of the target muscle compared to non-targeted muscles.
次要结局
未报告次要终点
研究者
Jason Carmel
Associate Professor
Columbia University