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临床试验/NCT02473549
NCT02473549已完成不适用

Towards More Successful Clinical Trials: Using a Patient-tailored Approach in Brain Stimulation to Improve Recovery of Movements After Stroke

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in accuracy of reaching (root mean square error) after 1 session of TDCS

研究概览

简要总结

Many individuals are often left with problems moving their arm and hand, months to even years after a stroke. Recent progress in research suggests the application of non-invasive brain stimulation, such as transcranial direct current stimulation (TDCS), in conjunction with rehabilitation exercises can further improve a person's ability to move after stroke. However, the problem is that this doesn't work for everyone, and researchers do not know why. One reason may be that TDCS is currently applied using a one-size-fits-all approach. Researchers apply the same type of TDCS to everyone, assuming the stroke affects everyone in the same way. But, researchers know this is not the case. For example, each person will likely have different amounts of damage to brain regions that control movements. A better understanding of how the stroke uniquely affects a person's brain will help us to know which is the correct type of TDCS to apply for that person. Therefore, the objective of this research is to determine whether the amount of damage to brain regions that control movements can predict which type of TDCS will be more effective to help a person improve their ability to move. Participants will undergo 1 session of magnetic resonance imaging, and three sessions of TDCS.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral first time stroke in middle cerebral artery territory
  • greater 3 months post-stroke
  • able to raise arm onto a table from a seated position

排除标准

  • severe cognitive or comprehension deficits that may compromise informed consent or understanding of instructions
  • severe apraxia and neglect
  • neurodegenerative or psychiatric disease
  • contraindications to MRI and TDCS (e.g. metal in head, pacemaker, claustrophobia)

结局指标

主要结局

Change in accuracy of reaching (root mean square error) after 1 session of TDCS

时间窗: 1 day

Change in efficiency of reaching (number of velocity peaks) after 1 session of TDCS

时间窗: 1 day

Change in movement time (seconds) for reaching after 1 session of TDCS

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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