Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Recruitment Rate
研究概览
简要总结
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ulnar neuropathy at the elbow
排除标准
- •Peripheral neuropathy outside of nerve of interest
- •Patients with any active implanted device
研究组 & 干预措施
Experimental Intervention
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
干预措施: Temporary Peripheral Nerve Stimulation System (Device)
Control
Standard of care only.
结局指标
主要结局
Recruitment Rate
时间窗: 1.5 years
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Retention Rate
时间窗: 1.5 years
Evaluation of study feasibility through the number of participants who complete all study activities
Eligibility Rate
时间窗: 1.5 years
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
次要结局
未报告次要终点