Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
研究概览
简要总结
50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50% females will participate in an interventional study in two groups: placebo and experimental group.
Placebo group will only receive traditional treatment with physiotherapy and the Experimental or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.
详细描述
In this Interventional Study with Double Blind Assignment to Placebo and Experimental Group, Gross Motor Function Measure (GMFM) and Neurophysiological are the parameters measured with EEG amplifier before and after 30 sessions.
Work hypothesis is that the tRNS Group will present better motor functionality after 30 sessions of 30 minutes of duration of electrical brain stimulation administered during physiotherapy exercises 2 days per week than the Group that only receives treatment with physiotherapy during 30 minutes 2 days per week without tRNS.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 3 and 7 years.
- •Meet criteria for Congenital or Acquired Brain Injury .
- •Patients who have been diagnosed at least 1 year before inclusion in the study.
排除标准
- •Acute visual or hearing loss.
- •Other neurological disorders: migraine, epilepsy, tuberous sclerosis
- •Other neurodevelopmental disorders like ASD, ADHD, PDD, etc ...
结局指标
主要结局
Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale
时间窗: Up to five months
Motor Functionality Scale
次要结局
- Differences in Power Fast Fourier Transformation before and after intervention(up to five months)