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
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