跳至主要内容
临床试验/NCT06001736
NCT06001736招募中不适用

Seventh Cervical Nerve Transfer for Spastic Arm Paresis: a Prospective Analysis of Efficacy in Ischemic Vs. Hemorrhagic Stroke

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
95
试验地点
2
主要终点
Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.

研究概览

简要总结

The purpose of this study is to evaluate the limb functional improvement after contralateral C7 root transfer in stroke patients.

详细描述

Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality of life, with loss of hand dexterity being especially prohibitive. In the recovery phase after initial injury, neural reorganization occurs and has been observed in both ipsilateral and contralateral hemispheres. Previous studies have identified contralesional (opposite to the side of the injury), in other words, ipsilateral, activation in the recovery of paretic hand function. However, this pathway of recovery is limited due to sparse connections between the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer, compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7 root transfer is an established procedure for the treatment of brachial plexus injuries and recently, for the treatment of spastic arm paresis in those with cerebral injury.

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation.

排除标准

  • pregnancy

结局指标

主要结局

Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.

时间窗: 12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.

The Fugl-Meyer is a widely used and highly recommended stroke-specific, performance-based measure of impairment with 5 domains and a possible 226 points.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Hong

Principal Investigator

Dartmouth-Hitchcock Medical Center

研究点 (2)

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