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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02940-9

摘要内容如下：

颈脊髓损伤（SCI）导致手臂和手功能的永久性损害。在此，我们进行了一项前瞻性、单臂、多中心、开放标签、无显著风险的试验，以评估ARCEX疗法改善慢性SCI患者手臂和手部功能的安全性和有效性。ARCEX疗法包括在结构性康复期间在颈髓上施加外部电刺激。主要终点是安全性和有效性，这是通过大多数参与者对ARCEX治疗的反应是否表现出力量和功能表现的显著改善来衡量的。60名参与者完成了协议。未报告与ARCEX治疗相关的严重不良事件，且达到了主要疗效终点。在力量和功能领域，72%的参与者表现出比最低重要差异标准更大的改善。次要终点分析显示，指尖捏力、手抓握和力量、上肢运动和感觉能力显著改善，自我报告的生活质量提高。这些结果证明了ARCEX疗法在改善颈部脊髓损伤患者的手和手臂功能方面的安全性和有效性。ClinicalTrials.gov标识符：NCT04697472。

英文原文如下：

Abstracts

Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .

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