RecruitingNot ApplicableNCT06722677

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

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)


Sponsor

Beijing Pins Medical Co., Ltd

Enrollment

99 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a small implanted nerve stimulator (vagus nerve stimulation, or VNS) with physical rehabilitation can help stroke survivors regain more arm and hand movement than rehab alone. **You may be eligible if...** - Age 22–79 - Had a stroke on one side of the brain (ischemic, not bleeding) at least 9 months ago but less than 10 years ago - Have some remaining arm weakness but still some movement (moderate impairment) - Able to understand and follow instructions - Willing to attend all follow-up visits **You may NOT be eligible if...** - Had a hemorrhagic (bleeding) stroke - Have swallowing or aspiration problems - Previous injury to the vagus nerve - Taking certain medications that affect brain chemical systems (e.g., certain antidepressants or blood pressure drugs) - Had Botox injections in the affected arm within the past 4 weeks - Have severe arm stiffness or severe loss of arm sensation - Have severe depression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVNS

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

DEVICESham VNS

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

OTHERRehabilitation

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

View Full Details on ClinicalTrials.gov

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NCT06722677


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