NCT07841431

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
25mo left

Started Oct 2026

Typical duration for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1.8 years

First QC Date

September 13, 2026

Last Update Submit

September 20, 2026

Conditions

StrokeRehabilitationVagus Nerve Stimulations

Keywords

StrokeRehabilitationVagus Nerve Stimulations

Outcome Measures

Primary Outcomes (1)

  • 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.

    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);

    90 days

  • Change from baseline in Wolf Motor Function Test (WMFT) score at 90 days

    90 days

  • Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) at 90 days

    90 days

Other Outcomes (7)

  • Change from baseline in Stroke Impact Scale (SIS) score at 90 days

    90 days

  • Change from baseline in Stroke-Specific Quality of Life (SS-QOL) score at 90 days

    90 days

  • Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index score at 90 days

    90 days

  • +4 more other outcomes

Study Arms (2)

Active VNS group

EXPERIMENTAL

After implantation, participants randomized to active VNS (0.8 mA) combined with upper limb rehabilitation.

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.

Other: Control VNS (0.0 mA)

Interventions

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.

Active VNS group
Control VNS (0.0 mA)OTHER

After implantation, participants randomized to Control VNS (0.8 mA) combined with upper limb rehabilitation.

Control VNS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xuesong Bai, Dr.

CONTACT

86 18810032664bxsben@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double-blind: participant-blinded and care provider-blinded. Participants' prognostic information was recorded in detail by two physicians blinded to treatment assignment during the hospital treatment period and at 1, 30, and 90 days after hospital treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 25, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The VNS-EARLY Steering Committee will consider on a case-by-case basis requests for data sharing.