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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
Placebo Comparator: Non-adaptive cognitive training
Non-adaptive cognitive training
Behavioral: Cognitive training
Experimental: Adaptive cognitive triaining
Adaptive cognitive training
Behavioral: Cognitive training
- NIH Toolbox-Cognition Battery [ Time Frame: 1 year ]
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
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Bruce E Compas, PhD||Vanderbilt University|