Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03687008 |
| Other study ID # |
92418 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 10, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
