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 time-on-target score.
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
To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 time-on-target score.
时间窗: 3 weeks
The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score.
次要结局
未报告次要终点
研究者
George Wittenberg
Professor
University of Pittsburgh