Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:7 - 16
Updated:9/8/2018
Start Date:February 1, 2014
End Date:December 31, 2017

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This research will leverage novel pilot research conducted by the investigators to take
important first steps in addressing neurocognitive late effects by intervening early, during
treatment, with a promising computerized cognitive remediation program to prevent the
downward trajectory of neurocognitive function experienced by pediatric brain tumor
survivors. Specifically, we propose to test the feasibility, acceptability, and initial proof
of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to train
working memory (WM) and attention in newly diagnosed youth with a brain tumor. Further, we
will test the feasibility of using this intervention in a true prospective design beginning
pre-surgery to examine the effects of this intervention in deflecting the downward trajectory
of cognitive function in children with brain tumors during treatment. We will also use
functional neuroimaging (near infrared spectroscopy - "NIRS") to examine the effects of this
program on brain activation in frontal regions that are affected by treatment. Findings from
this pilot study will inform the development of a large multi-site randomized efficacy trial
to test an individualized cognitive training program.

Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with
newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks,
delivering the Cogmed computer-based training program in a randomized trial at 10-weeks
post-diagnosis, and following patients to 1 year post-diagnosis.

Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on
cognitive function in newly diagnosed pediatric brain tumor patients.

Over 4,000 children are diagnosed with brain tumors in the U.S. each year and advances in
treatment have led to significant increases in survival rates for these patients. However, as
a result of the disease and treatment with surgery, radiation, and chemotherapy, pediatric
brain tumor patients show deficits in frontal lobe functions including several aspects of
executive function, showing significant declines over time. Remediation of these deficits is
a critical target for research. Major changes in brain maturation and connectivity occur
during childhood and adolescence, making this a potentially critical window of opportunity
for neuroplasticity-based cognitive interventions to support the neural changes that
integrate multiple key regions. Computerized cognitive training programs have been used
successfully with patients with schizophrenia, individuals with ADHD, and prodromal
adolescents at risk for psychosis. However, these programs have been limited in their
application to pediatric brain tumor survivors and untested in brain tumor patients who are
undergoing treatment. We aim to blend longitudinal and intervention research designs used
successfully in previous studies to test the feasibility, acceptability, and initial efficacy
of a neuroplasticiy-based cognitive training program, Cogmed, to enhance working memory and
attention in children and adolescents who have been diagnosed with brain tumors. First, we
will use a longitudinal design in which, in collaboration with Dr. Wellons (pediatric
neurosurgeon) and Dr. Friedman (pediatric hematology/oncology), we will recruit patients at
the time of their diagnosis and conduct cognitive testing pre-surgery and at approximately 10
weeks post diagnosis (randomization), 5-7 weeks post Cogmed start (post-intervention), 10-20
weeks post Cogmed start (follow-up), and 1 year post diagnosis (long term follow-up). Second,
we will embed a test of the efficacy of Cogmed in this longitudinal design by randomizing
patients at 10-weeks post-diagnosis. Half will undergo Cogmed computerized adaptive cognitive
training (treatment condition) for 5 weeks and half will be assigned to the non adaptive
Cogmed computerized cognitive training (control condition). We will use near infrared
spectroscopy, a noninvasive functional imaging method that uses infrared light to detect
changes in cortical hemoglobin levels at randomization, post-intervention, follow-up, and
long term follow-up. We expect that Cogmed, which will be administered at home or in the
hospital, will be feasible and acceptable for the majority (85% or more) of patients.
Further, we hypothesize that adaptive Cogmed training will help improve working memory and
attention skills and increase frontal cortical activity in the brain tumor patients who
receive the remediation program compared to those who receive the non-adaptive control
version of the program. Using growth curve analyses, we expect that patients who receive the
intervention will show a deflection in the negative trajectory of cognitive functions over
time. Findings from this pilot study will be used to develop an application for a multi-site
randomized clinical trial to test this intervention in a large sample of pediatric brain
tumor patients.

Inclusion Criteria:

- Newly diagnosed brain tumor patients who are between the ages of 7 years and 16 years,
11 months old and their parents

- Patients and their parents must be fluent English speakers

Exclusion Criteria:

- Patient's brain tumor diagnosis cannot be a recurrence of a previous cancer

- No previous history of another form of cancer

- Patients who are deemed legally blind will be excluded from participating
We found this trial at
1
site
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Phone: 615-322-8290
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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