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临床试验/NCT02747394
NCT02747394已完成不适用

Cognitive Training for Fragile X Syndrome

University of California, Davis2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory

研究概览

简要总结

Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • fragile X full mutation
  • normal or corrected vision
  • English or Spanish speaking
  • ability to pass three-span items following completion of a Cogmed training session at baseline
  • parental agreement to maintain adherence to the training schedule and to not alter other treatments during the study unless medically necessary

排除标准

  • previous Cogmed training
  • significant medical problems that would interfere with the study or significant brain trauma

研究组 & 干预措施

Adaptive Cogmed

Experimental

5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed

干预措施: Working Memory Training (Other)

Non-Adaptive Cogmed

Other

5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed

干预措施: Working Memory Training (Other)

结局指标

主要结局

Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory

时间窗: 5-6 weeks

Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory

次要结局

  • Wechsler Intelligence Scale for Children-IV Digit Span(3 month followup)
  • Kiddie Test of Attentional Performance (KiTAP)(3 month followup)
  • Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)(3 month followup)
  • Swanson, Nolan and Pelham (SNAP-IV)(3 month followup)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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