Intracerebral Hemorrhage, Stroke, Upper Extremity Motor Function
Conditions
Keywords
upper limb rehabilitation, invasive vagus nerve stimulation, intracerebral hemorrhage, neuromodulation
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.
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.
Interventions
DEVICEInvasive Vagus Nerve Stimulation
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.
Sponsors
Beijing Chao Yang Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Documented history of stroke with persistent upper-limb motor dysfunction. 3. Completion of invasive vagus nerve stimulation implantation. 4. Completion of paired upper-limb rehabilitation after stimulation. 5. Availability of clinical assessments during follow-up.
Exclusion criteria
1. Other central nervous system disorders affecting motor function assessment. 2. Severe disturbance of consciousness or inability to complete standardized functional assessments. 3. Severe cognitive, communication, musculoskeletal, or peripheral nerve disorders interfering with upper-limb function evaluation. 4. Missing key clinical or follow-up data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score | 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. |
Countries
China
Outcome results
None listed