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Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors (CRPBT)

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ClinicalTrials.gov Identifier: NCT02129712
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Compas, Vanderbilt University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Brain Tumor Behavioral: Cognitive training Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Placebo Comparator: Non-adaptive cognitive training
Non-adaptive cognitive training
Behavioral: Cognitive training
Experimental: Adaptive cognitive triaining
Adaptive cognitive training
Behavioral: Cognitive training



Primary Outcome Measures :
  1. NIH Toolbox-Cognition Battery [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02129712


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bruce E Compas, PhD Vanderbilt University

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Responsible Party: Bruce Compas, Patricia and Rodes Hart Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02129712     History of Changes
Other Study ID Numbers: 121214
1R21CA175840-01 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases