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A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)

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研究单位: [1]Beijing Pins Medical Co., Ltd [2]The First Affiliated Hospital of USTC,Hefei,Anhui,China,230022 [3]Beijing Tiantan Hospital, Capital Medical University,Beijing,Beijing,China,100000 [4]Chinese People''s Liberation Army General Hospital,Beijing,Beijing,China,100039 [5]The Xin Qiao Hospital of Army Medical University,Chongqing,Chongqing,China,400037 [6]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China,350004 [7]Zhujiang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510260 [8]Jiangbin Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China,530012 [9]Tongji Hospital Tongji Medical College of HUST,Wuhan,Hubei,China,430030 [10]Brain Hospital of Hunan Province The Second People''s Hospital of Hunan Province,Changsha,Hunan,China,410000 [11]Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School,Nanjing,Jiangsu,China,210008 [12]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330006 [13]The First Bethune Hospital of Jilin University,Changchun,Jilin,China,130021 [14]Qilu Hospital of Shandong University,Jinan,Shandong,China,250012 [15]Huashan Hospital, Fudan University,Shanghai,Shanghai,China,200040 [16]West China Hospital, Sichuan University,Chengdu,Sichuan,China,618099 [17]The First Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China,650032

关键词: Stroke Ischemic Stroke Paresis Upper Extremity Paresis Vagus Nerve Stimulation Neuromodulation Randomized Controlled Trial Rehabilitation

研究目的:
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke. Researchers will compare the outcomes of active VNS paired with rehabilitation against sham VNS (the actual intensity is 0 mA) also paired with rehabilitation, in order to assess improvements in arm motor function post-stroke. Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.

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