Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Score
研究概览
简要总结
Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.
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
- Double (Participant, Outcomes Assessor)
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
- •first-ever ischemic or hemorrhagic stroke at least 1 year earlier
- •hand function impairment
- •ability to give informed consent and comprehend instructions
排除标准
- •previous surgical intervention on vagus nerve
- •low hearth rate (< 60 bpm)
- •cognitive impairment or any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- •excessive pain in any joint of the paretic extremity
- •advanced liver, kidney, cardiac or pulmonary disease
- •history of significant alcohol or drug abuse
- •depression or use of neuropsychotropic drugs such as antidepressants or benzodiazepines
- •pregnant women
结局指标
主要结局
Change in Fugl-Meyer Score
时间窗: immediately, one months and three months after the intervention
次要结局
- Change in kinematic data (Movement Duration) measured by the robot(immediately, one months and three months after the intervention)
- Incidence of adverse events that are related to treatment(intervention period of 10 consecutive working days)
- Change in kinematic data (Motion Accuracy) measured by the robot(immediately, one months and three months after the intervention)
- Change in kinematic data (Motion Direction) measured by the robot(immediately, one months and three months after the intervention)
- Change in kinematic data (Smoothness) measured by the robot(immediately, one months and three months after the intervention)
- Change in kinematic data (Speed) measured by the robot(immediately, one months and three months after the intervention)
- Change in kinematic data (Efficiency) measured by the robot(immediately, one months and three months after the intervention)
研究者
Di Lazzaro Vincenzo
Full Professor of Neurology
Campus Bio-Medico University