A Retrospective Cohort Study of Invasive Vagus Nerve Stimulation Paired With Rehabilitation for Upper Limb Dysfunction After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
时间窗: 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.
次要结局
未报告次要终点