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RECRUITING
NCT06722677
NA

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

Sponsor: Beijing Pins Medical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DEVICE

VNS

An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.

DEVICE

Sham VNS

An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.

OTHER

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