StrokeVNS-EARLYNCT07841431
Neuromodulation for Functional Recovery After Stroke
A study testing active VNS (0.8 mA) in people with Stroke and Rehabilitation, run by Xuanwu Hospital, Beijing.
Trial summary
This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Rehabilitation, Vagus Nerve Stimulations
- What is being tested?
- active VNS (0.8 mA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of unilateral supratentorial ischemic stroke and in the subacute phase (3-6 months);
- Age between 18-80 years, both male and female;
- FMA-UE score of 20-50 (inclusive);
- Ability to communicate, understand, and provide appropriate consent; participant can follow two-step commands;
- Right or left upper limb weakness;
- Active flexion/extension of the wrist or fingers;
- Informed consent signed by the patient or a family member.
Who cannot join
- History of hemorrhagic stroke;
- Persistent dysphagia or choking/coughing while eating or drinking;
- Medications that, at study initiation, may significantly interfere with the effects of VNS on neurotransmitter systems;
- Prior vagus nerve injury, bilateral or unilateral (e.g., injury during carotid endarterectomy);
- Severe or more severe depression (Beck Depression Inventory >29);
- Candidates unsuitable for device implantation surgery (e.g., history of adverse reaction to anesthesia, deemed unsuitable as a surgical candidate by the surgeon, etc.);
Show all 12Show fewer
- Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug;
- Preexisting neurological or psychiatric disorders before stroke onset that affect assessment of the condition;
- Pregnancy, planned pregnancy, or breastfeeding during the study period;
- Severe upper limb spasticity (modified Ashworth ≥3);
- Severe sensory loss. Sensory loss will be measured using the upper extremity sensory portion of the Fugl-Meyer Assessment. The assessment involves light touch (two items) and proprioception (four items). The maximum score is 12; subjects with a score below 6 will be excluded from the study;
- Other conditions that the investigator considers unsuitable for participation or that may pose a significant risk to the patient.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group.
This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.
Read the detailed description
This study uses a multicenter, double-blind, randomized controlled design. Eligible participants all undergo implantation of a VNS device and are randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. The study hypothesizes that vagus nerve stimulation is effective in improving upper limb motor function in patients in the subacute phase after stroke; that is, a meaningful difference in FMA-UE scores exists between the active VNS group and the control group at the end of 6 weeks of hospital treatment. All enrolled participants undergo implantation of a vagus nerve stimulation device. After preoperative assessment, patients undergo implantation of the vagus nerve stimulation device under general anesthesia. After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). This trial uses the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity, with a pretreatment baseline assessment performed 1 week after implantation. Stimulation testing is performed in 0.1 mA increments in both groups to assess the level at which participants can perceive and tolerate stimulation. Hospital treatment begins on the day after baseline assessment.
- Conditions
- Stroke, Rehabilitation, Vagus Nerve Stimulations
- Being tested
- active VNS (0.8 mA), Control VNS (0.0 mA)
- Keywords
- Stroke, Rehabilitation, Vagus Nerve Stimulations
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active VNS (0.8 mA)Other
After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). To reduce the risk of participants inferring treatment assignment, participants in both treatment groups receive five stimuli of decreasing intensity at the beginning of each treatment session (starting at 0.8 mA and then decreasing by 0.1 mA at each step), after which treatment is administered according to randomization.
Control VNS (0.0 mA)Other
After implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Active VNS group | Experimental | After implantation, participants randomized to active VNS (0.8 mA) combined with upper limb rehabilitation. Receives: Other: active VNS (0.8 mA) |
| Control VNS group | Sham comparator | After implantation, participants randomized to control VNS (0 mA) combined with upper limb rehabilitation. Receives: Other: Control VNS (0.0 mA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment.
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Measured: At the end of 6 weeks of hospital treatment.
Secondary outcomes (3)
Clinically meaningful improvement in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days (≥6-point improvement in FMA-UE score);
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Measured: 90 days
Change from baseline in Wolf Motor Function Test (WMFT) score at 90 days
The WMFT Functional Ability Scale ranges from 0 to 75, with higher scores indicating better upper-extremity function.
Measured: 90 days
Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841431
- Sponsor's protocol ID
- VNS-EARLY
- Acronym
- VNS-EARLY
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The VNS-EARLY Steering Committee will consider on a case-by-case basis requests for data sharing.
Publications
1. 王拥军, et al., 中国卒中报告2019（中文版）（1）. 中国卒中杂志, 2020. 15(10): p. 1037-1043. 2. Nakayama, H., et al., Recovery of upper extremity function in stroke patients: The Copenhage n stroke study. Archives of Physical Medicine and Rehabilitation. 75(4): p. 394-398. 3. Opara, J.A. and K. Jaracz, Quality of life of post-stroke patients and their caregivers. J Med Life, 2010. 3(3): p. 216-20. 4. Butt, M.F., et al., The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat, 2020. 236(4): p. 588-611. 5. van der Meij, A. and M.J.H. Wermer, Vagus nerve stimulation: a potential new treatment for ischaemic strok e. Lancet (London, England). 397(10284): p. 1520-1521. 6. Ay, I., et al., Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Isch emic Injury in Rats. Brain stimulation. 9(2): p. 166-73. 7. Kimberley, T.J., et al., Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Ch ronic Stroke. Stroke. 49(11): p. 2789-2792. 8. Dawson, J., et al., Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke, 2016. 47(1): p. 143-50. 9. Dawson, J., et al., Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet, 2021. 397(10284): p. 1545-1553. 10. Grefkes, C. and G.R. Fink, Recovery from stroke: current concepts and future perspectives. Neurological Research and Practice, 2020. 2(1): p. 17.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Functional Recovery After Stroke
- ClinicalTrials.gov ID
- NCT07841431
- Acronym / sponsor ID
- VNS-EARLY / VNS-EARLY
- Conditions
- Stroke, Rehabilitation, Vagus Nerve Stimulations
- Keywords
- Stroke, Rehabilitation, Vagus Nerve Stimulations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 25 Sep 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 used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group.
This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.
Detailed description
This study uses a multicenter, double-blind, randomized controlled design. Eligible participants all undergo implantation of a VNS device and are randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. The study hypothesizes that vagus nerve stimulation is effective in improving upper limb motor function in patients in the subacute phase after stroke; that is, a meaningful difference in FMA-UE scores exists between the active VNS group and the control group at the end of 6 weeks of hospital treatment. All enrolled participants undergo implantation of a vagus nerve stimulation device. After preoperative assessment, patients undergo implantation of the vagus nerve stimulation device under general anesthesia. After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). This trial uses the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity, with a pretreatment baseline assessment performed 1 week after implantation. Stimulation testing is performed in 0.1 mA increments in both groups to assess the level at which participants can perceive and tolerate stimulation. Hospital treatment begins on the day after baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VNS group | Experimental | Other: active VNS (0.8 mA)After implantation, participants randomized to active VNS (0.8 mA) combined with upper limb rehabilitation. |
| Control VNS group | Sham comparator | Other: Control VNS (0.0 mA)After implantation, participants randomized to control VNS (0 mA) combined with upper limb rehabilitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of unilateral supratentorial ischemic stroke and in the subacute phase (3-6 months);
- Age between 18-80 years, both male and female;
- FMA-UE score of 20-50 (inclusive);
- Ability to communicate, understand, and provide appropriate consent; participant can follow two-step commands;
- Right or left upper limb weakness;
Key exclusion criteria (12 listed)
- History of hemorrhagic stroke;
- Persistent dysphagia or choking/coughing while eating or drinking;
- Medications that, at study initiation, may significantly interfere with the effects of VNS on neurotransmitter systems;
- Prior vagus nerve injury, bilateral or unilateral (e.g., injury during carotid endarterectomy);
- Severe or more severe depression (Beck Depression Inventory >29);
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 |
|---|---|---|
| active VNS (0.8 mA)After implantation, participants are randomized 1:1 to active VNS (0.8 mA) combined with upper limb rehabilitation or control VNS (0.0 mA). To reduce the risk of participants inferring treatment assignment, participants in both treatment groups receive five stimuli of decreasing intensity at the beginning of each treatment session (starting at 0.8 mA and then decreasing by 0.1 mA at each step), after which treatment is administered according to randomization. | Other | Active VNS group |
| Control VNS (0.0 mA)After implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation. | Other | Control VNS group |
Primary outcome
The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment.
Time frame: At the end of 6 weeks of hospital treatment.
The FMA-UE total score ranges from 0 to 66, with higher scores indicating better upper-extremity motor function.
3 secondary outcomes
Clinically meaningful improvement in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days (≥6-point improvement in FMA-UE score);
Time frame: 90 days
Change from baseline in Wolf Motor Function Test (WMFT) score at 90 days
Time frame: 90 days
Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background1. 王拥军, et al., 中国卒中报告2019（中文版）（1）. 中国卒中杂志, 2020. 15(10): p. 1037-1043. 2. Nakayama, H., et al., Recovery of upper extremity function in stroke patients: The Copenhage n stroke study. Archives of Physical Medicine and Rehabilitation. 75(4): p. 394-398. 3. Opara, J.A. and K. Jaracz, Quality of life of post-stroke patients and their caregivers. J Med Life, 2010. 3(3): p. 216-20. 4. Butt, M.F., et al., The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat, 2020. 236(4): p. 588-611. 5. van der Meij, A. and M.J.H. Wermer, Vagus nerve stimulation: a potential new treatment for ischaemic strok e. Lancet (London, England). 397(10284): p. 1520-1521. 6. Ay, I., et al., Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Isch emic Injury in Rats. Brain stimulation. 9(2): p. 166-73. 7. Kimberley, T.J., et al., Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Ch ronic Stroke. Stroke. 49(11): p. 2789-2792. 8. Dawson, J., et al., Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke, 2016. 47(1): p. 143-50. 9. Dawson, J., et al., Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet, 2021. 397(10284): p. 1545-1553. 10. Grefkes, C. and G.R. Fink, Recovery from stroke: current concepts and future perspectives. Neurological Research and Practice, 2020. 2(1): p. 17.
- Individual participant dataSharing planned: No. The VNS-EARLY Steering Committee will consider on a case-by-case basis requests for data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing active VNS (0.8 mA) in people with Stroke and Rehabilitation, run by Xuanwu Hospital, Beijing.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuesong Bai, Dr. (86 18810032664, bxsben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) scores between the active VNS group and the control group at the end of 6 weeks of hospital treatment. (time frame: At the end of 6 weeks of hospital treatment.). 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 NCT07841431, 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 25 Sep 2026.