Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors

May 19, 2026 updated by: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

The goal of this study is to learn if an online computerized training program improves processing speed in children with pediatric brain tumors. The main questions it aims to answer are:

  1. Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?
  2. Is the cognitive intervention acceptable to patients and caregivers?
  3. Does the cognitive intervention improve neuropsychological functioning?

There is no comparison group for this study.

Participants will:

  1. Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks.
  2. Have weekly check-ins with the cognitive coach.
  3. Fill out acceptability surveys at the end of the cognitive intervention.
  4. Complete pre- and post- neuropsychological testing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute
        • Contact:
        • Principal Investigator:
          • Rachel K Peterson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with a primary tumor located in the brain
  2. Diagnosed between 0 and 25 years of age
  3. Within five years of cancer diagnosis
  4. Receiving care at Johns Hopkins Hospital

Exclusion Criteria:

  1. Patients with a primary tumor outside of the brain
  2. Patients too young to participate in the cognitive intervention (<5 years)
  3. Patients with severe brain injuries that precludes them from understanding and participating in the cognitive intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Intervention
Computerized cognitive training program focused on processing speed.
Behavioral: Online computerized cognitive training intervention focused on processing speed.
This online cognitive intervention aims to improve processing speed through individualized, computerized cognitive exercises. A cognitive coach selects a set of cognitive exercises for each participant based on identified needs, cognitive ability, and age. Participants complete 15 minutes of training, 5 times per week for 8 weeks, for a target total of approximately 10 hours of training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platform Engagement - Logins
Time Frame: 8 weeks
Total number of logins recorded over the intervention period.
8 weeks
Platform Engagement - Task Completion
Time Frame: 8 weeks
Total number of completed cognitive training levels
8 weeks
Engagement Barriers
Time Frame: Weekly during 8-week intervention
Participant-reported engagement and barriers measured using a Likert-scale questionnaire administered weekly during the intervention. Mean total score will be reported. Qualitative feedback regarding barriers and facilitators to engagement will also be collected to provide descriptive context.
Weekly during 8-week intervention
Acceptability
Time Frame: Week 8
Participant-reported acceptability measured using a Likert-scale questionnaire administered at the end of the intervention. Mean total score will be reported. Qualitative feedback regarding participant experience will also be collected to provide descriptive context.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance-based Cognitive Functioning
Time Frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Changes in processing speed as measured by the NIH toolbox.
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Parent and Self-report Measures of Cognitive Functioning
Time Frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
Change in cognitive functioning as measured by the PROMIS Cognitive Function Child and Parent Proxy surveys
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

  • Principal Investigator: Rachel K Peterson, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 6, 2026

Primary Completion (Estimated)

May 6, 2031

Study Completion (Estimated)

April 1, 2033

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00519695

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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