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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Ischemic Stroke, Upper Extremity Paresis

In brief

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.

Key facts

Study ID

NCT06722677

Run by

Beijing Pins Medical Co., Ltd

People needed

99

Starts

2024-11-19

Expected to finish

2025-11-01

Last updated by the study team

2024-12-10

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History of hemorrhagic stroke.
• Presence of ongoing dysphagia or aspiration difficulties.
• Prior injury to vagus nerve, either bilateral or unilateral.
• Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation follow-up timepoint, or home rehabilitation follow-up timepoint, such as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc.
• Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
• Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
• Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score < 6).
• Severe depression (Beck Depression Scale > 29).
• Current requirement, or likely future requirement, of diathermy.
• Current use of any other stimulation device, such as a pacemaker or other neurostimulator.
• Pregnancy or plans to become pregnant or to breastfeed during the study period.
• Participated in any other clinical trials within the preceding 3 months.
• Not considered to be applicable by the investigator.

Where it is running

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (enrolling)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (enrolling)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province — Changsha, Hunan, 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 USTC — Hefei, Anhui, 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
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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