Cognitive Rehabilitation Combined to Transcranial Direct Current Stimulation Following Traumatic Brain Injury: Functional Magnetic Resonance Imaging Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
研究概览
简要总结
The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.
详细描述
Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe traumatic brain injury
- •more than 3 months since the onset
- •Attentional disorders (PASAT test (score ≤ centile 10) and/or CANTAB test (≤ -2 standard deviation)
- •Women having contraceptive treatment (for the magnetic resonance imaging exam)
排除标准
- •inability to undergo magnetic resonance imaging scan
- •No attentional impairment (PASAT ≥ centile10)
- •Severe depression
- •Neurological disease
- •Major cognitive impairment (aphasia, neglect)
- •Drugs addiction
- •Pregnant women and women having no contraceptive treatment
结局指标
主要结局
intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task).
时间窗: 12 weeks
次要结局
- Intergroup differences in neuropsychological score(12 weeks)
- Intergroup differences in resting activation maps.(12 weeks)
- Correlation between activation extend and attentional outcomes(12 weeks)
- Intergroup differences in diffusion measures(12 weeks)
- Intergroup differences in polymorphisms(12 weeks)