Cognitive Intervention to Improve Working Memory
Primary Purpose
Single Ventricle Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Computer Based Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Single Ventricle Heart Disease focused on measuring Cognition, Working Memory, Magnetic Resonance Imaging, Cogmed
Eligibility 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
Sites / Locations
- UCLA 300 Medical Plaza
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adolescents with SVHD
Arm Description
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].
Outcomes
Primary Outcome Measures
Changes in Working Memory Index [WMI] Scores
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
Changes in Mean Diffusivity [MD] Values [brain tissue changes]
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).
Full Information
NCT ID
NCT03687008
First Posted
September 25, 2018
Last Updated
September 19, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03687008
Brief Title
Cognitive Intervention to Improve Working Memory
Official Title
Cognitive Intervention to Improve Working Memory in Adolescents With Single Ventricle Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Ventricle Heart Disease
Keywords
Cognition, Working Memory, Magnetic Resonance Imaging, Cogmed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one group, pre- post-intervention design
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescents with SVHD
Arm Type
Experimental
Arm Description
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].
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Computer Based Intervention
Other Intervention Name(s)
Cogmed Version 4.0
Intervention Description
25 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches
Primary Outcome Measure Information:
Title
Changes in Working Memory Index [WMI] Scores
Description
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].
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Changes in Mean Diffusivity [MD] Values [brain tissue changes]
Description
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).
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Pike, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA 300 Medical Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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Cognitive Intervention to Improve Working Memory
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