NCT05721261招募中不适用
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 22
- 主要终点
- Sensory recovery
研究概览
简要总结
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Peripheral nerve injury
排除标准
- •Peripheral neuropathy
- •Patients with any active implanted device
研究组 & 干预措施
Active treatment
Experimental
干预措施: Temporary Peripheral Nerve Stimulation System (Device)
Sham treatment
Sham Comparator
干预措施: Sham Temporary Peripheral Nerve Stimulation System (Device)
结局指标
主要结局
Sensory recovery
时间窗: 6 months
Cumulative incidence of adverse events
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (22)
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