Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of serious adverse events related to vagus nerve stimulation or therapy
研究概览
简要总结
The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Ischemic stroke ≥6 months prior to enrollment.
- •Post-stroke lower extremity impairment defined as gait velocity of less than 0.8 m/s on a 10-meter walk test
- •Provision of informed consent
排除标准
- •Intracerebral Hemorrhage
- •Active or prior psychosis or substance abuse within two years.
- •Pre-stroke modified Rankin Scale (mRS) 3-
- •Unable to participate in in-clinic rehabilitation.
- •Preexisting neurological disorders affecting gait and mobility, such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, major head trauma.
研究组 & 干预措施
Chronic ischemic stroke
Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training.
干预措施: Vagus nerve stimulation (VNS) paired with mobility training (Other)
结局指标
主要结局
Number of serious adverse events related to vagus nerve stimulation or therapy
时间窗: 1 year
Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training
Number of participants to complete the study
时间窗: 1 year
Total number of participants to complete a minimum of 18 therapy sessions
Change in Instrumented Gait Assessment score
时间窗: Baseline, 12 months
Gait speed is calculated as the predetermined distance divided by the time to walk that distance, reported in meters per second (m/s). Improvement in gait velocity is ≥0.05 m/s .
次要结局
未报告次要终点