Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors

NCT02129712 | Completed DMC

• 2 other identifiers: 1212141R21CA175840-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• NIH Toolbox-Cognition Battery

  1 year

Study Arms (2)

Non-adaptive cognitive training

PLACEBO COMPARATOR

Non-adaptive cognitive training

Behavioral: Cognitive training

Adaptive cognitive triaining

EXPERIMENTAL

Adaptive cognitive training

Behavioral: Cognitive training

Interventions

Cognitive training BEHAVIORAL

Adaptive cognitive triaining; Non-adaptive cognitive training

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bruce E Compas, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patricia and Rodes Hart Professor

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: February 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

US (1)