Rehabilitation with Vagus Nerve Stimulation for Stroke Recovery

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)

This study tests if adding vagus nerve stimulation to rehabilitation can help people recover better use of their arms after having a stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 22 Years to 80 Years
• Sex: All
• Sponsor: Beijing Pins Medical Co., Ltd (Industry-sponsored)
• Locations: 16 sites (Hefei, Anhui and 15 other locations)
• Trial ID: NCT06722677 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of vagus nerve stimulation (VNS) combined with rehabilitation to improve upper extremity motor function in patients who have suffered an ischemic stroke. Participants will undergo a surgical procedure to implant a VNS system and will receive a structured rehabilitation program over 18 weeks, including both in-clinic and home exercises. The study compares outcomes between those receiving active VNS and those receiving a sham VNS to determine the impact on motor function recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 80 who have experienced a unilateral ischemic stroke at least 9 months prior and have specific levels of upper extremity motor function.

Not a fit: Patients with a history of hemorrhagic stroke or ongoing swallowing difficulties may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance motor recovery in stroke patients, improving their quality of life.

How similar studies have performed: While the combination of VNS and rehabilitation is a novel approach, similar studies have shown promise in enhancing recovery in other neurological conditions.

Eligibility criteria

Inclusion Criteria:

1. Age ≥22 years and \<80 years, all gender is acceptable.
2. History of unilateral supratentorial ischemic stroke ≥ 9 months but \< 10 years.
3. Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.
4. Right- or left-sided weakness of upper extremity.
5. Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.
6. Subjects have good compliance and can complete the visits after surgery.

Exclusion Criteria:

1. History of hemorrhagic stroke.
2. Presence of ongoing dysphagia or aspiration difficulties.
3. Prior injury to vagus nerve, either bilateral or unilateral.
4. 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.
5. Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).
6. Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).
7. Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \< 6).
8. Severe depression (Beck Depression Scale \> 29).
9. Current requirement, or likely future requirement, of diathermy.
10. Current use of any other stimulation device, such as a pacemaker or other neurostimulator.
11. Pregnancy or plans to become pregnant or to breastfeed during the study period.
12. Participated in any other clinical trials within the preceding 3 months.
13. Not considered to be applicable by the investigator.

Where this trial is running

Hefei, Anhui and 15 other locations

• The First Affiliated Hospital of USTC — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Xin Qiao Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Jiangbin Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Recruiting)
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (Recruiting)
• Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)

Study contacts

• Study coordinator: Jianguang Sun

Conditions Ischemic Stroke; Upper Extremity Paresis; Stroke; Paresis; Vagus Nerve Stimulation; Neuromodulation; Randomized Controlled Trial; Rehabilitation