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A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)
Sponsor: Beijing Pins Medical Co., Ltd
Summary
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.
Official title: A Multi-Center, Triple-Blind, Randomized, Sham-Controlled Trial Assessing the Efficacy and Safety of Rehabilitation Paired with Vagus Nerve Stimulation for Upper Extremity Motor Function in Patients with Ischemic Stroke (Repair Study)
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2024-11-19
Completion Date
2025-11
Last Updated
2024-12-10
Healthy Volunteers
No
Conditions
Interventions
VNS
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.
Sham VNS
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.
Rehabilitation
Rehabilitation movements to improve upper limb function after stroke.
Locations (16)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
The Xin Qiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China
Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China