Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): Cognitive training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment