Cognitive Intervention to Improve Working Memory
Condition: Single Ventricle Heart Disease
MeSH terms: Heart Diseases; Univentricular Heart
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Computer Based Intervention
Intervention type(s): Behavioral
Intervention description(s): 25 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches
Other intervention name(s): Cogmed Version 4.0
Intervention model: Single Group Assignment
Intervention model description: one group, pre- post-intervention design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognition; Working Memory; Magnetic Resonance Imaging; Cogmed