NCT01279655终止不适用
The Influence of a tDCS Combined Long-term Motor Training Program on Structural White Matter Changes in the Brain, Functionality and Psychological Outcome Measures in Multiple Sclerosis.
Hasselt University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in White Matter
研究概览
简要总结
In the current study the researchers will firstly investigate whether a bimanual coordination training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white matter architecture and improved upper-limb functionality in patients with multiple sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor cortex.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
- •Stable MS (no relapse during the last 3 months before study onset)
- •age: between 18 and 68 years
排除标准
- •Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication.
- •Standard TMS/tDCS and MRI exclusion criteria (safety questionnaires)
结局指标
主要结局
Change in White Matter
时间窗: Baseline, immediately after and 3 weeks after the intervention
Diffusion Tensor Imaging (DTI) T1 structural scan Fluid-attenuated inversion recovery Scan (FLAIR) Magnetization Transfer Imaging (MTI)
次要结局
- Change in Quality of Life(Baseline, immediately after and 3 weeks after the intervention)
- Blood sample(After the end of the study)
研究者
Koen Cuypers
Drs
Hasselt University
研究点 (2)
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