Invasive Vagus Nerve Stimulation Paired With Rehabilitation After Stroke

NCT07736573 | Completed

• 1 other identifier: CYH-VNS-Stroke-2025-001
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Intracerebral Hemorrhage; Upper Extremity Motor Function

Keywords

upper limb rehabilitation; invasive vagus nerve stimulation; intracerebral hemorrhage; neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks after initiation of rehabilitation

Interventions

Invasive Vagus Nerve Stimulation DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start: January 10, 2025
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)