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Cognitive Intervention to Improve Working Memory

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ClinicalTrials.gov Identifier: NCT03687008
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nancy Pike, PhD, RN, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Single Ventricle Heart Disease Behavioral: Cognitive Computer Based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: one group, pre- post-intervention design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Intervention to Improve Working Memory in Adolescents With Single Ventricle Heart Disease
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adolescents with SVHD
All adolescents will receive the intervention Cogmed. This is an in home, computer based, cognitive intervention to improve working memory, supervised by trained coaches, [25 sessions, each 30-45 minutes, 5 days a week / 5 week duration].
Behavioral: Cognitive Computer Based Intervention
25 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches
Other Name: Cogmed Version 4.0




Primary Outcome Measures :
  1. Changes in Working Memory Index [WMI] Scores [ Time Frame: 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].


Secondary Outcome Measures :
  1. Changes in Mean Diffusivity [MD] Values [brain tissue changes] [ Time Frame: Baseline, 6 weeks ]
    To be measured non-invasively via brain MRI using diffusion tensor imaging (DTI) techniques, which measure mean diffusivity (MD) values (increased values indicate worse tissue injury).



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687008


Contacts
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Contact: Nancy Pike, PhD 3102063683 npike@sonnet.ucla.edu

Locations
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United States, California
UCLA 300 Medical Plaza Recruiting
Los Angeles, California, United States, 90095
Contact: Nancy Pike, PhD    310-903-2614    npike@sonnet.ucla.edu   
Principal Investigator: Nancy Pike, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Nancy Pike, PhD University of California, Los Angeles
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Responsible Party: Nancy Pike, PhD, RN, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03687008    
Other Study ID Numbers: 92418
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Pike, PhD, RN, University of California, Los Angeles:
Cognition
Working Memory
Magnetic Resonance Imaging
Cogmed
Additional relevant MeSH terms:
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Heart Diseases
Univentricular Heart
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities