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Could a nerve stimulator restore arm movement after stroke?

NCT ID NCT06722677

Disease control Sponsor: Beijing Pins Medical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether pairing vagus nerve stimulation (VNS) with rehabilitation can improve arm function in people who have had an ischemic stroke. Participants receive an implanted VNS device and undergo weeks of therapy, with some receiving active stimulation and others a sham (inactive) device. The study measures changes in arm motor function using a standard stroke recovery scale. The goal is to see if VNS adds meaningful benefit to rehabilitation alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vagus nerve stimulation (VNS) delivered by an implanted device, paired with rehabilitation therapy
What this could lead to
If it works, this could offer a new way to improve arm movement and independence for people living with long-term weakness after a stroke.
What could go wrong
The trial is small and early, and the effect may not be large or lasting. The treatment requires surgery to implant the device, which carries surgical risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

99 people

The number who actually took part.

Started

Nov 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke Paresis stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Upper extremity paresis

Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000, China

  • Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province

    Changsha, Hunan, 410000, China

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Jiangbin Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530012, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School

    Nanjing, Jiangsu, 210008, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of USTC

    Hefei, Anhui, 230022, China

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Xin Qiao Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400037, China

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, 430030, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510260, China

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