Improving Bi-manual Activities in Stroke Patients With Application of Neuro-stimulation
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- bimanual coordination
研究概览
简要总结
Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.
Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.
A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.
详细描述
tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in chronic stroke patients with motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during performance of bimanual activities and/or motor learning. A few minutes/hours/days/weeks after completing one trial's arm, the patients will enter the other trial's arm (double-blind cross-over design).
Baseline and follow-up outcomes about bimanual and unimanual motor tasks will be collected.
For a subset of subjects, motor learning and data acquisition will be performed with a neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •stroke with at least slight deficit
排除标准
- •contraindication to tDCS and/or to fMRI
- •presence of metal in the head
- •inability to understand / complete behavioral tasks
- •chronic intake of alcohol or recreational drugs
- •major health condition
- •presence of pacemaker (for the fMRI part only)
- •pregnancy
结局指标
主要结局
bimanual coordination
时间窗: up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention
The effect of intervention on bimanual motor coordination will be quantified before, during and after executive tasks.
次要结局
- standard unimanual evaluation(immediately, 30, 60 min; and up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention))
研究者
Pr Yves Vandermeeren, MD, PhD
Professer Yves Vandermeeren
University Hospital of Mont-Godinne