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Impact of VNS With Rehab on Gait Post-Stroke

2026年6月8日 更新者：Assaf Berger、State University of New York at Buffalo

The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.

This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.

Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.

研究类型

介入性

注册 (估计的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Ellen M Carl, PhD, CCRP
  • 电话号码：7260 716-218-1000
  • 邮箱：ecarl@ubns.com

研究联系人备份

学习地点

  • 美国
    • New York
      • Buffalo、New York、美国、14203
        • 招聘中
        • University at Buffalo Neurosurgery
        • 接触：
          • Ellen M Carl, PhD, CCRP
          • 电话号码：7260 716-218-1000
          • 邮箱：ecarl@ubns.com
        • 接触：
        • 首席研究员：
          • Assaf Berger, MD
        • 副研究员：
          • Jonathan Riley, MD
        • 副研究员：
          • Sue Ann Sisto, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
  • ≥22 years and ≤ 80 years
  • Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
  • Residual active movement in the affected limb's thumb and other 2 fingers
  • Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
  • Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person

Exclusion Criteria:

  • Intact lower limb functions (Fugl-Meyer score=34)
  • Not a candidate for VNS therapy according to FDA guidelines
  • Pregnant patients

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：VNS ON
Receives active stimulation during therapy
设备：Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
假比较器：VNS OFF
No stimulation during therapy
设备：Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
大体时间：90 days post-operation
Absolute change in FMA-LE from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
大体时间：90 days post-operation
Percent change in FMA-LE from baseline to 90 days
90 days post-operation

次要结果测量

结果测量
措施说明
大体时间
Absolute Change in Functional Assessment - 10-meter walk
大体时间：90 days post-operation
Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 10-meter walk
大体时间：90 days post-operation
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - 6-minute walk
大体时间：90 days post-operation
Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 6-minute walk
大体时间：90 days post-operation
Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Berg Balance Scale
大体时间：90 days post-operation
Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Berg Balance Scale
大体时间：90 days post-operation
Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
大体时间：90 days post-operation
Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
大体时间：90 days post-operation
Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Stroke Impact Scale
大体时间：90 days post-operation
Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Stroke Impact Scale
大体时间：90 days post-operation
Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
大体时间：90 days post-operation
Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
大体时间：90 days post-operation
Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
90 days post-operation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

State University of New York at Buffalo

调查人员

  • 首席研究员：Assaf Berger, MD、University at Buffalo

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年12月15日

研究完成 (估计的)

2028年2月23日

研究注册日期

首次提交

2026年5月23日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00008984

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

IPD will likely be shared but a plan has not yet been finalized.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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