StrokeVNS-StrokeNCT07736573
Invasive Vagus Nerve Stimulation Paired With Rehabilitation After Stroke
An observational study of Stroke and Upper Extremity Motor Function, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This study evaluated the feasibility, safety, and preliminary functional outcomes of invasive vagus nerve stimulation (iVNS) paired with upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Motor Function, Intracerebral Hemorrhage
- What is being tested?
- Invasive Vagus Nerve Stimulation
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2025to 15 Mar 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic stroke-related upper-limb motor dysfunction who underwent invasive vagus nerve stimulation paired with rehabilitation at Beijing Chao-Yang Hospital, Capital Medical University.
Who may be able to join
- Adults aged 18 years or older.
- Documented history of stroke with persistent upper-limb motor dysfunction.
- Completion of invasive vagus nerve stimulation implantation.
- Completion of paired upper-limb rehabilitation after stimulation.
- Availability of clinical assessments during follow-up.
Who cannot join
- Other central nervous system disorders affecting motor function assessment.
- Severe disturbance of consciousness or inability to complete standardized functional assessments.
- Severe cognitive, communication, musculoskeletal, or peripheral nerve disorders interfering with upper-limb function evaluation.
- Missing key clinical or follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
Official title: A Retrospective Cohort Study of Invasive Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Dysfunction After Stroke
This study evaluated the feasibility, safety, and preliminary functional outcomes of invasive vagus nerve stimulation (iVNS) paired with upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Participants received cervical iVNS implantation followed by a 6-week supervised rehabilitation program and subsequent home-based rehabilitation. Changes in upper-limb motor function, spasticity, quality of life, and safety outcomes were assessed. Exploratory neuroimaging assessments using positron emission tomography/computed tomography and arterial spin labeling were performed in selected participants to evaluate changes in brain metabolism and perfusion.
Read the detailed description
Stroke is a major cause of long-term disability, and upper-limb motor impairment is one of the most common and disabling consequences after stroke. Vagus nerve stimulation (VNS) paired with rehabilitation is a neuromodulation approach designed to enhance activity-dependent neural plasticity during motor training.
This single-center study investigated the clinical feasibility and preliminary effects of invasive vagus nerve stimulation paired with structured upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Participants underwent left cervical vagus nerve stimulation implantation and completed a 6-week supervised in-clinic rehabilitation program followed by a 90-day home-based rehabilitation phase.
Clinical outcomes included the Fugl-Meyer Assessment Upper Extremity score, additional motor and sensory functional assessments, Modified Ashworth Scale scores for spasticity evaluation, and health-related quality of life assessment. Safety and stimulation-related tolerability were also evaluated throughout follow-up.
Exploratory imaging analyses using positron emission tomography/computed tomography and arterial spin labeling were conducted in selected participants to describe changes in metabolic activity and cerebral perfusion within motor-related cortical and subcortical regions.
The study provides preliminary clinical observations regarding the application of invasive vagus nerve stimulation paired with rehabilitation for stroke-related motor recovery and may support future controlled clinical studies.
- Being tested
- Invasive Vagus Nerve Stimulation
- Keywords
- upper limb rehabilitation, invasive vagus nerve stimulation, intracerebral hemorrhage, neuromodulation
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive Vagus Nerve StimulationDevice
Participants received left cervical invasive vagus nerve stimulation using an implanted pulse generator and electrode system, combined with structured upper-limb rehabilitation. Stimulation parameters were adjusted according to individual tolerance. Rehabilitation included supervised in-clinic training followed by home-based rehabilitation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment Upper Extremity score from baseline after invasive vagus nerve stimulation paired rehabilitation.
Measured: 6 weeks after initiation of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start10 Jan 2025
- Primary completion15 Dec 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736573
- Sponsor's protocol ID
- CYH-VNS-Stroke-2025-001
- Acronym
- VNS-Stroke
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei D, Qing W, Zhang H, Ma C, Luan W, Peng Y, Yu C, Ji X, Liu J, Zhang J, Li S, Liang F, Liu C. Invasive vagus nerve stimulation paired with upper limb motor rehabilitation after intracerebral hemorrhage: A single-arm pilot cohort study. Neural Regen Res. 2026 Oct 20. doi: 10.4103/NRR.NRRONLINE-D-26-00873. Online ahead of print.
PubMed 42899841
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study of Invasive Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Dysfunction After Stroke
- ClinicalTrials.gov ID
- NCT07736573
- Acronym / sponsor ID
- VNS-Stroke / CYH-VNS-Stroke-2025-001
- Keywords
- upper limb rehabilitation, invasive vagus nerve stimulation, intracerebral hemorrhage, neuromodulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 30 Jul 2026 (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.
This study evaluated the feasibility, safety, and preliminary functional outcomes of invasive vagus nerve stimulation (iVNS) paired with upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Participants received cervical iVNS implantation followed by a 6-week supervised rehabilitation program and subsequent home-based rehabilitation. Changes in upper-limb motor function, spasticity, quality of life, and safety outcomes were assessed. Exploratory neuroimaging assessments using positron emission tomography/computed tomography and arterial spin labeling were performed in selected participants to evaluate changes in brain metabolism and perfusion.
Detailed description
Stroke is a major cause of long-term disability, and upper-limb motor impairment is one of the most common and disabling consequences after stroke. Vagus nerve stimulation (VNS) paired with rehabilitation is a neuromodulation approach designed to enhance activity-dependent neural plasticity during motor training.
This single-center study investigated the clinical feasibility and preliminary effects of invasive vagus nerve stimulation paired with structured upper-limb rehabilitation in participants with chronic stroke-related upper-limb motor dysfunction. Participants underwent left cervical vagus nerve stimulation implantation and completed a 6-week supervised in-clinic rehabilitation program followed by a 90-day home-based rehabilitation phase.
Clinical outcomes included the Fugl-Meyer Assessment Upper Extremity score, additional motor and sensory functional assessments, Modified Ashworth Scale scores for spasticity evaluation, and health-related quality of life assessment. Safety and stimulation-related tolerability were also evaluated throughout follow-up.
Exploratory imaging analyses using positron emission tomography/computed tomography and arterial spin labeling were conducted in selected participants to describe changes in metabolic activity and cerebral perfusion within motor-related cortical and subcortical regions.
The study provides preliminary clinical observations regarding the application of invasive vagus nerve stimulation paired with rehabilitation for stroke-related motor recovery and may support future controlled clinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic stroke-related upper-limb motor dysfunction who underwent invasive vagus nerve stimulation paired with rehabilitation at Beijing Chao-Yang Hospital, Capital Medical University.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Documented history of stroke with persistent upper-limb motor dysfunction.
- Completion of invasive vagus nerve stimulation implantation.
- Completion of paired upper-limb rehabilitation after stimulation.
- Availability of clinical assessments during follow-up.
Key exclusion criteria (4 listed)
- Other central nervous system disorders affecting motor function assessment.
- Severe disturbance of consciousness or inability to complete standardized functional assessments.
- Severe cognitive, communication, musculoskeletal, or peripheral nerve disorders interfering with upper-limb function evaluation.
- Missing key clinical or follow-up data.
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 |
|---|---|---|
| Invasive Vagus Nerve StimulationParticipants received left cervical invasive vagus nerve stimulation using an implanted pulse generator and electrode system, combined with structured upper-limb rehabilitation. Stimulation parameters were adjusted according to individual tolerance. Rehabilitation included supervised in-clinic training followed by home-based rehabilitation. | Device | – |
Primary outcome
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Time frame: 6 weeks after initiation of rehabilitation
Change in upper-limb motor function assessed by the Fugl-Meyer Assessment Upper Extremity score from baseline after invasive vagus nerve stimulation paired rehabilitation.
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 30 Jul 2026.
- Derived from this study: PubMed 42899841Wei D, Qing W, Zhang H, Ma C, Luan W, Peng Y, Yu C, Ji X, Liu J, Zhang J, Li S, Liang F, Liu C. Invasive vagus nerve stimulation paired with upper limb motor rehabilitation after intracerebral hemorrhage: A single-arm pilot cohort study. Neural Regen Res. 2026 Oct 20. doi: 10.4103/NRR.NRRONLINE-D-26-00873. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Upper Extremity Motor Function, run by Beijing Chao Yang Hospital at 1 site 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 5 inclusion and 4 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score (time frame: 6 weeks after initiation of rehabilitation). 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 NCT07736573, which also lists 1 linked publication.
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 30 Jul 2026.