NCT04732936已完成不适用
Feasibility Study of a Temporary Peripheral Nerve Stimulator
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Static Two Point Discrimination
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
结局指标
主要结局
Static Two Point Discrimination
时间窗: 6 months
Measurement of spatial determination
Semmes-Weinstein Monofilament Test
时间窗: 6 months
Measurement of pressure sensitivity
DASH Questionnaire
时间窗: 6 months
Validated questionnaire for functionality in upper extremity injury
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 (6)
Loading locations...
相似试验
尚未招募
不适用
Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps MuscleSpinal Cord InjuriesBrain InjuriesMuscle AtrophyNCT05888714University of Sao Paulo General Hospital15
已完成
不适用
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in HomeOveractive BladderNCT03595215Theranova, L.L.C.18
已完成
不适用
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2Postacute Sequelae of Sars-CoV-2Post-Acute COVID-19 SyndromeWidespread Chronic PainFatigue Syndrome, ChronicGait, UnsteadyNCT05200858Baylor College of Medicine30
已完成
1 期
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral NervesUnilateral Carpal Tunnel SyndromeNCT00665132Bioness Inc10
终止
不适用
Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)Chemotherapy-induced Peripheral NeuropathyPainNeuropathyNCT06324344Baylor College of Medicine10