Mechanisms of Non-invasive Vagus Nerve Stimulation Underlying Enhanced Motor Control in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in size of evoked potential
研究概览
简要总结
The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.
详细描述
Non-invasive stimulation techniques can be used to appropriately time converging inputs to induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory protocol known as paired-associative stimulation (PAS). Experiments seek to examine interactions between cortical PAS and non-invasive vagus nerve stimulation (VNS) to understand the extent to which VNS amplifies cortical plasticity in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INDIVIDUALS WHO HAVE HAD A STROKE:
- •Diagnosis of first ever stroke
- •At least 6 months after stroke onset
- •Motor-evoked potentials in hand/arm muscles
- •Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.
- •ALL INDIVIDUALS:
- •Between the ages of 18 and 75 years old
排除标准
- •INDIVIDUALS WHO HAVE HAD A STROKE:
- •Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators
- •ALL INDIVIDUALS:
- •Neurological disorder(s) influencing movement (besides stroke)
- •History of seizure or epilepsy
- •Metallic brain implants
- •Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
- •Pregnant or expecting to become pregnant
- •Difficulty maintaining alertness and/or remaining still
- •Silicone or plastic allergy
- •History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
结局指标
主要结局
Change in size of evoked potential
时间窗: 1 week
The primary endpoint is the change from baseline (ie, before PAS) in the size of evoked potentials. Differences in the change between conditions (ie, PAS+VNS vs PAS+Sham) will address whether VNS drives cortical plasticity.
次要结局
未报告次要终点
研究者
George Wittenberg
Professor
University of Pittsburgh