NCT04732936已完成不适用
Feasibility Study of a Temporary Peripheral Nerve Stimulator
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- DASH Questionnaire
研究概览
简要总结
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between 18-65 years old
- •Have a Sunderland II-V peripheral nerve injury of the upper extremity
- •Are receiving surgery within 14 days of injury
排除标准
- •Nerve plexus injuries (e.g. brachial plexus)
- •Nerve gap requiring graft/conduit, or extreme joint flexion
- •Polyneuropathies
- •Cognitive impairment and non-English-speaking
- •Uncontrolled diabetes
- •Surgical intervention > 14 days of injury
- •Co-enrollment in another clinical trial
- •Pregnant women
研究组 & 干预措施
Device Usability
Experimental
Device usability and safety will be evaluated.
干预措施: Temporary Peripheral Nerve Stimulator (Device)
Preliminary Efficacy
Experimental
Preliminary treatment efficacy will be evaluated.
干预措施: Temporary Peripheral Nerve Stimulator (Device)
结局指标
主要结局
DASH Questionnaire
时间窗: 6 months
Validated questionnaire for functionality in upper extremity injury
Semmes-Weinstein Monofilament Test
时间窗: 6 months
Measurement of pressure sensitivity
Static Two Point Discrimination
时间窗: 6 months
Measurement of spatial determination
Patient Tolerance to Therapy Questionnaire
时间窗: Immediately after procedure
次要结局
- Device Usability Questionnaire(Immediately after procedure)
- Safety(6 months)
研究者
研究点 (3)
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