NCT02616796已完成1 期
Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Percentage of social gaze aversion recorded during the social challenge
研究概览
简要总结
The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys diagnosed with fragile X syndrome
- •Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
- •Age 8 to 18 years inclusive
- •Ability to travel to Stanford
- •Vineland Adaptive Behavior Scales standard score between 50 and 75 points
排除标准
- •Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
- •Materials in body that would preclude an MRI scan (e.g., dental braces).
结局指标
主要结局
Percentage of social gaze aversion recorded during the social challenge
时间窗: 3 days
Total t-score on the Social Responsiveness Scale (SRS)
时间窗: 4 weeks
Heart rate recorded during the social challenge
时间窗: 3 days
次要结局
- Verbal responses and pauses in conversation observed during the social challenge(3 days)
- Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex(3 days)
研究者
Scott Hall
Associate Professor
Stanford University
研究点 (2)
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