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临床试验/NCT03687008
NCT03687008已完成不适用

Cognitive Intervention to Improve Working Memory in Adolescents With Single Ventricle Heart Disease

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年6月10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
5
试验地点
2
主要终点
Changes in Working Memory Index [WMI] Scores

研究概览

简要总结

Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.

详细描述

Adolescents with single ventricle heart disease (SVHD) show brain injuries in sites (hippocampus, mammillary bodies, thalamus, and frontal cortices) that are associated with cognitive deficits, in particular working memory. A key component of cognition, and thus, an important influence on academic performance, self-care ability, quality of life, and morbidity and mortality, is working memory. However, it is unclear whether cognition, as well as brain tissue integrity can be improved with cognition intervention. Among available interventions, a possible intervention to improve working memory and brain status in SVHD is Cogmed®, which is an interactive, computer-based intervention, specifically designed for children and young adults, to improve attention and working memory with significant effectiveness in other pediatric conditions associated with brain injury. A unique feature of the Cogmed ® program is the in-home support of trained coaches for the duration of the intervention (5 days/week for 5 weeks), which optimizes adherence and confirms completion of the tasks. The investigators will use a one group pre- post-intervention design, 20 subjects (10 males and 10 females), with inclusion criteria: 14-18 years of age, have undergone surgical palliation, and score 25-10 (mild to moderate cognitive impairment) on the Montreal Cognitive Assessment (MoCA) screener. Using non-invasive brain magnetic resonance imaging (MRI) procedures, diffusion tensor imaging (DTI) based mean diffusivity (MD), an MRI measure of tissue integrity, can identify changes in the hippocampus, mammillary bodies, thalamus, and frontal cortices pre- and post- cognitive intervention. Therefore, the specific aims of this proposal are to: 1) examine the impact of Cogmed® intervention on working memory (working memory index [WMI] score from the WRAML2) in adolescents with SVHD (pre- and post-intervention); 2) assess the effect of Cogmed® on brain structural integrity (DTI-based MD procedures) in sites that control memory (hippocampus, mammillary bodies, thalamus, and frontal cortices) in adolescents with SVHD (pre- and post-intervention); and 3) examine if there is an impact of the Cogmed® intervention on cognition and brain tissue integrity based on sex in SVHD.

In summary, SVHD adolescents have significant cognitive deficits that are linked to brain injury in regions, which control such functions. Intervention to improve cognition and brain injury in SVHD is unclear, but a potential innovative treatment for such symptoms and brain injury is Cogmed®. The information from this pilot study has the potential to revolutionize the clinical treatment specific to cognitive deficits in SVHD and other types of congenital heart defects. In addition, the clinical implications are considerable as improved working memory skill has the potential to increase academic achievement, improve self-care, reduce mortality and morbidity, and increase quality of life in this high risk, growing population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • be 14-18 years old
  • have SVHD
  • undergone Fontan completion
  • understands English
  • able to read computer screen
  • have phone access
  • MoCA score of 25 to 10

排除标准

  • pregnancy
  • claustrophobia
  • presence of loose metal
  • prior head injury or stroke
  • clinical diagnosis of depression
  • previous cardiac arrest and ECMO use
  • currently listed for heart transplant
  • known genetic syndrome
  • severe developmental delay
  • born less than 35 weeks gestation

结局指标

主要结局

Changes in Working Memory Index [WMI] Scores

时间窗: Baseline, 6 weeks

To be measured by the Wide Range Assessment of Memory and Learning, version 2 \[WRAML 2\], working memory index \[mean 100, SD 15\] subscale. This is an administered test by trained personnel which measures all aspects of memory \[visual, verbal, working memory, attention / concentration\]. Lower scores indicate worse working memory deficits \[1 SD below normal is \< 85\].

次要结局

  • Changes in Mean Diffusivity [MD] Values [brain tissue changes](Baseline, 6 weeks)

研究者

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

Nancy Pike, PhD, RN

Professor

University of California, Los Angeles

研究点 (2)

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