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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:
• Age ≥22 years and \<80 years, all gender is acceptable.
• History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 years.
• Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
• Right- or left-sided weakness of upper extremity.
• Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.
• Subjects have good compliance and can complete the visits after surgery.
Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Chinese People's Liberation Army General Hospital
NOT_YET_RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province
NOT_YET_RECRUITING
Changsha
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The Xin Qiao Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of USTC
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School
NOT_YET_RECRUITING
Nanjing
Jiangbin Hospital of Guangxi Zhuang Autonomous Region