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临床试验/NCT04323488
NCT04323488已完成不适用

Neural Mechanisms of Successful Intervention in Children With Dyslexia

Stanford University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年5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
90
试验地点
2
主要终点
White Matter Plasticity - Left Arcuate Tract

研究概览

简要总结

Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with reading education programs, to generate a new understanding of how successful reading education shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Reading difficulties defined as low scores on standardized measures of reading skills

排除标准

  • no major contraindication for MRI (braces, metal implants, pacemakers, vascular stents, or metallic ear tubes).
  • Because the study involves measurements of reading and language ability, new recruits will be native English speakers.
  • Subjects have no history of neurological disorder, significant psychiatric problems
  • exclude claustrophobic subjects since an MRI might be uncomfortable for them.

结局指标

主要结局

White Matter Plasticity - Left Arcuate Tract

时间窗: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter.

White Matter Plasticity - Inferior Longitudinal Tract

时间窗: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

Change in white matter mean diffusivity (MD) measured with diffusion MRI. MD quantifies the average magnitude of water diffusion within a given region of tissue. An increase in mean diffusivity (MD) suggests an increase in free water movement (corresponds to less white matter integrity), while a decrease in MD suggests restricted water diffusion, potentially from increased cellular density (corresponds to greater white matter integrity). Values typically range from approximately 0.5 to 1.5 × 10\^-3 mm²/s in healthy white matter.

Visual Word Form Area (VWFA) Size

时间窗: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

Visual Word Form Area (VWFA) refers to a region in the brain associated with the recognition of written words. VWFA size is calculated as the number of vertices in the cotrical surface. There are no definitive clinical relevant thresholds for the size of the VWFA that apply universally. Research indicates that variations in VWFA size and activation are associated with reading abilities and disorders.

Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery

时间窗: Baseline (within 2 weeks pre-intervention), post-intervention (within 2 weeks post-intervention, up to 10 weeks), and at 1 year follow up

The Woodcock-Johnson Basic Reading Skills (WJ BRS) Assessment Battery results in a composite score across multiple assessments. Assessment scores are transformed to create an overall score range of 0 to 200. A score of 100 indicates average reading ability. Scores below 85 may indicate potential reading difficulties

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Yeatman

Assistant Professor

Stanford University

研究点 (2)

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