Ischemic StrokeNCT06722677
A Trial of Rehabilitation Paired With VNS for Motor Function in Patients With Stroke (Repair Study)
A study testing VNS and Rehabilitation in people with Ischemic Stroke and Upper Extremity Paresis, run by Beijing Pins Medical Co., Ltd at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Ischemic Stroke, Upper Extremity Paresis
- What is being tested?
- VNS and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 13 sitesChina
- Study dates
- 19 Nov 2024to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Brain Hospital of Hunan Province The Second People's Hospital of Hunan Province
Changsha, Hunan, 410000
The Xin Qiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510260
The First Affiliated Hospital of USTC
Hefei, Anhui, 230022
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing university Medical School
Nanjing, Jiangsu, 210008
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530012
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
About this study
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)
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.
Read the detailed description
There are 6 follow-up timepoints in this trial:
- Screening follow-up timepoint (V1): All participants will sign the informed consent form and receive pre-implant evaluation, including physical examination, brain magnetic resonance imaging, FMA-UE, WMFT, modified Ashworth sacle, BDI, ect.
- Surgery follow-up timepoint (V2):All participants will be implanted with the VNS system, including the G115R IPG and L312 lead.
- Baseline follow-up timepoint (V3): There is a baseline evaluation 7 to 14 days after the surgery, then participants will be randomly assigned to VNS group or Control group. The randomization will be stratified by baseline FMA-UE (20 to 35, 36 to 50), age (<50, ≥50) and research center (south centers, north centers).
- Clinic rehabilitation follow-up timepoint (V4): Participants will receive standard clinic rehabilitation 3 days per week and lasting 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. Participants will be evaluated at the last day of this follow-up timepoint.
- Home exercise follow-up timepoint (V5): Participants will take standard home exercise everyday in 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. At the last day, after evaluating, group assignment is unblinded.
- Unmasking follow-up timepoint (V6): In this 6 weeks, all participants will receive active VNS. Participants in VNS group will still take standard home exercise, and participants in Control group will receive standard clinic rehabilitation again. Participants will be also evaluated at the last day of this follow-up timepoint.
- Conditions
- Ischemic Stroke, Upper Extremity Paresis
- Being tested
- VNS, Sham VNS, Rehabilitation
- Keywords
- Stroke, Ischemic Stroke, Paresis, Upper Extremity Paresis, Vagus Nerve Stimulation, Neuromodulation, Randomized Controlled Trial, Rehabilitation
- Medical subject headings
- Ischemic Stroke, Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNSDevice
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.
Sham VNSDevice
An neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.
RehabilitationOther
Rehabilitation movements to improve upper limb function after stroke.
| Study group | Role | What they receive |
|---|---|---|
| VNS group | Experimental | Active VNS paired with rehabilitation Receives: Device: VNS; Other: Rehabilitation |
| Control group | Active comparator | Sham VNS paired with rehabilitation Receives: Device: Sham VNS; Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The FMA-UE will be analyzed for difference in average change at Clinic rehabilitation follow-up timepoint compared to Baseline follow-up timepoint (Difference in average change in FMA-UE from V3 to V4).
Measured: V4, 6 weeks after Baseline follow-up timepoint
Secondary outcomes (10)
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response
The Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response is the percent of patients with a 6 point or greater improvement on the FMA-UE.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Measured: V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Average Change
The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal).
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Response
Wolf Motor Function Test (WMFT) Response is the percent of patients with a 0.4 point or greater improvement on the WMFT.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
Beck Depression Inventory (BDI) Average Change
The Beck Depression Inventory (BDI) is a self-report questionnaire used to identify overt behavioral characteristics of depression. Items are scored on a 4-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0 to 63.
Measured: V6, 6 weeks after Home exercise follow-up timepoint
Montreal Cognitive Assessment (MoCA) Average Change
MoCA is designed to assess cognitive function in patients. It assesses a number of different cognitive domains, including visuospatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score is 30, with higher scores indicating better cognitive function.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Motor Activity Log (MAL) Average Change
The Motor Activity Log (MAL) consists of 30 activities of daily living such as using a towel, brushing teeth, and picking up a glass. The individual is asked to rate how often and how well each activity was performed with the more impaired arm. The response scale ranges from zero (never used) to 5 (same as pre-stroke)
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Stroke impact scale (SIS) Average Change
The Stroke Impact Scale (SIS) is a self-reported measure of stroke outcomes. Each item is selfrated on a 5-point Likert scale in terms of the difficulty the person has experienced in completing them after the score.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
EQ-5D-3L Average Change
The EQ-5D-3L is a general measure of health outcomes in any population. It is a self-report questionnaire which provides a simple descriptive profile and a single index value for health status.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Incidence of Adverse Events
The incidence of adverse events occurred during the clinical trial, whether or not related to the device.
Measured: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start19 Nov 2024
- Primary completion20 Jan 2026
- Study completion18 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722677
- Sponsor's protocol ID
- G115R&PINS-C2-01-53
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
PubMed 33894832Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.
PubMed 31903435Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.
PubMed 32476617Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.
PubMed 31685853Dawson J, Engineer ND, Cramer SC, Wolf SL, Ali R, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Feng W, Liu CY, Francisco GE, Brown BL, Dixit A, Alexander J, DeMark L, Krishna V, Kautz SA, Majid A, Tarver B, Turner DL, Kimberley TJ. Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial. Neurorehabil Neural Repair. 2023 Jun;37(6):367-373. doi: 10.1177/15459683221129274. Epub 2022 Oct 13.
PubMed 36226541Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
PubMed 26645257Hays SA, Khodaparast N, Hulsey DR, Ruiz A, Sloan AM, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves functional recovery after intracerebral hemorrhage. Stroke. 2014 Oct;45(10):3097-100. doi: 10.1161/STROKEAHA.114.006654. Epub 2014 Aug 21.
PubMed 25147331Hays SA, Khodaparast N, Sloan AM, Fayyaz T, Hulsey DR, Ruiz AD, Pantoja M, Kilgard MP, Rennaker RL 2nd. The bradykinesia assessment task: an automated method to measure forelimb speed in rodents. J Neurosci Methods. 2013 Mar 30;214(1):52-61. doi: 10.1016/j.jneumeth.2012.12.022. Epub 2013 Jan 23.
PubMed 23353133Khodaparast N, Kilgard MP, Casavant R, Ruiz A, Qureshi I, Ganzer PD, Rennaker RL 2nd, Hays SA. Vagus Nerve Stimulation During Rehabilitative Training Improves Forelimb Recovery After Chronic Ischemic Stroke in Rats. Neurorehabil Neural Repair. 2016 Aug;30(7):676-84. doi: 10.1177/1545968315616494. Epub 2015 Nov 4.
PubMed 26542082Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
PubMed 23954448Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving function and activities of daily living in patients after stroke. Cochrane Database Syst Rev. 2013 Nov 15;(11):CD009645. doi: 10.1002/14651858.CD009645.pub2.
PubMed 24234980Plow EB, Carey JR, Nudo RJ, Pascual-Leone A. Invasive cortical stimulation to promote recovery of function after stroke: a critical appraisal. Stroke. 2009 May;40(5):1926-31. doi: 10.1161/STROKEAHA.108.540823. Epub 2009 Apr 9.
PubMed 19359643Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009 Mar 17;6:8. doi: 10.1186/1743-0003-6-8.
PubMed 19292910Adkins DL, Hsu JE, Jones TA. Motor cortical stimulation promotes synaptic plasticity and behavioral improvements following sensorimotor cortex lesions. Exp Neurol. 2008 Jul;212(1):14-28. doi: 10.1016/j.expneurol.2008.01.031. Epub 2008 Feb 20.
PubMed 18448100Barbay S, Nudo RJ. The effects of amphetamine on recovery of function in animal models of cerebral injury: a critical appraisal. NeuroRehabilitation. 2009;25(1):5-17. doi: 10.3233/NRE-2009-0495.
PubMed 19713615
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06722677
- Acronym / sponsor ID
- G115R&PINS-C2-01-53
- Conditions
- Ischemic Stroke, Upper Extremity Paresis
- Keywords
- Stroke, Ischemic Stroke, Paresis, Upper Extremity Paresis, Vagus Nerve Stimulation, Neuromodulation, Randomized Controlled Trial, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are 6 follow-up timepoints in this trial:
- Screening follow-up timepoint (V1): All participants will sign the informed consent form and receive pre-implant evaluation, including physical examination, brain magnetic resonance imaging, FMA-UE, WMFT, modified Ashworth sacle, BDI, ect.
- Surgery follow-up timepoint (V2):All participants will be implanted with the VNS system, including the G115R IPG and L312 lead.
- Baseline follow-up timepoint (V3): There is a baseline evaluation 7 to 14 days after the surgery, then participants will be randomly assigned to VNS group or Control group. The randomization will be stratified by baseline FMA-UE (20 to 35, 36 to 50), age (<50, ≥50) and research center (south centers, north centers).
- Clinic rehabilitation follow-up timepoint (V4): Participants will receive standard clinic rehabilitation 3 days per week and lasting 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. Participants will be evaluated at the last day of this follow-up timepoint.
- Home exercise follow-up timepoint (V5): Participants will take standard home exercise everyday in 6 weeks. Active VNS (VNS group) or sham VNS (Control group) will be paired with rehabilitation. At the last day, after evaluating, group assignment is unblinded.
- Unmasking follow-up timepoint (V6): In this 6 weeks, all participants will receive active VNS. Participants in VNS group will still take standard home exercise, and participants in Control group will receive standard clinic rehabilitation again. Participants will be also evaluated at the last day of this follow-up timepoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS group | Experimental | Device: VNS, Other: RehabilitationActive VNS paired with rehabilitation |
| Control group | Active comparator | Device: Sham VNS, Other: RehabilitationSham VNS paired with rehabilitation |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNSAn neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve. | Device | VNS group |
| Sham VNSAn neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA. | Device | Control group |
| RehabilitationRehabilitation movements to improve upper limb function after stroke. | Other | Control group, VNS group |
Primary outcome
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint
The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment). The FMA-UE will be analyzed for difference in average change at Clinic rehabilitation follow-up timepoint compared to Baseline follow-up timepoint (Difference in average change in FMA-UE from V3 to V4).
10 secondary outcomes
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
Time frame: V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Response
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
Beck Depression Inventory (BDI) Average Change
Time frame: V6, 6 weeks after Home exercise follow-up timepoint
Montreal Cognitive Assessment (MoCA) Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Motor Activity Log (MAL) Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Stroke impact scale (SIS) Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
EQ-5D-3L Average Change
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Incidence of Adverse Events
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 33894832Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
- Background: PubMed 31903435Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.
- Background: PubMed 32476617Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.
- Background: PubMed 31685853Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.
- Background: PubMed 36226541Dawson J, Engineer ND, Cramer SC, Wolf SL, Ali R, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Feng W, Liu CY, Francisco GE, Brown BL, Dixit A, Alexander J, DeMark L, Krishna V, Kautz SA, Majid A, Tarver B, Turner DL, Kimberley TJ. Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Motor Impairment and Function After Chronic Ischemic Stroke: Subgroup Analysis of the Randomized, Blinded, Pivotal, VNS-REHAB Device Trial. Neurorehabil Neural Repair. 2023 Jun;37(6):367-373. doi: 10.1177/15459683221129274. Epub 2022 Oct 13.
- Background: PubMed 26645257Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VNS and Rehabilitation in people with Ischemic Stroke and Upper Extremity Paresis, run by Beijing Pins Medical Co., Ltd at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change (time frame: V4, 6 weeks after Baseline follow-up timepoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722677, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.