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NCT Number: NCT07558473

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

The goal of this study is to learn if an online computerized training program improves processing speed, attention, and working memory in children with a primary brain tumor during and after active cancer treatment. 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 children and caregivers?, and 3. Does the cognitive intervention improve neuropsychological functioning?

There is no comparison group for this study.

Participants will:

1. Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks; 2. Have weekly check-ins with the cognitive coach, 3. Complete a survey at the end of the cognitive training program, and 4. Complete pre- and post- neuropsychological testing.

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Key information

Conditions

Brain Tumor, Pediatric Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location contact

Emily J Amsden, BS

CONTACT

[email protected]

215-316-2343

Rachel K Peterson, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of a primary brain tumor,
  • Children and young adults 5 to 25 years of age at the time of enrollment,
  • Within five years of initial brain tumor diagnosis,
  • Receiving care through the Johns Hopkins neuro-oncology program.

Exclusion criteria

  • Significant visual, hearing, motor, or cognitive impairment that precludes participation in computerized cognitive training program;
  • Acute medical status (e.g., significant risk for mortality within 3-months of diagnosis).

Treatment and study plan

Online computerized cognitive training intervention focused on processing speed.

Behavioral

This online cognitive training program aims to improve processing speed through computerized cognitive exercises. Participants will complete approximately 15 minutes of training, 5 days per week for 8 weeks. Weekly check-ins with a cognitive coach will assist with engagement and problem solve any barriers.

Primary outcomes

  1. Feasibility - Enrollment

    Time frame: Up to 5 years after diagnosis.

    Study enrollment rate.

  2. Feasibility - Participant Retention

    Time frame: 8 weeks

    Number of participants who complete the computerized brain training program.

  3. Feasibility - Intervention Adherence

    Time frame: Through study completion, an average of 8 weeks.

    Number of levels completed in the cognitive training program. Qualitative feedback regarding barriers and facilitators to engagement will also we collected to provide descriptive context.

  4. Feasibility - Total Intervention Time

    Time frame: 8 weeks

    Total time spent completing the cognitive training program exercises.

  5. Acceptability

    Time frame: At the end of the 8-week intervention.

    Parent and self-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.

Secondary outcomes

  1. Cognitive Training Task-Based Performance

    Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.

    Changes in neuropsychological functioning, as measured by the train-to-task activity.

  2. Processing Speed

    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.

  3. Attention

    Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.

    Changes in attention as measured by the NIH toolbox.

  4. Working Memory

    Time frame: Prior to the intervention, immediately following intervention, and 6 months after intervention completion.

    Changes in working memory as measured by the NIH toolbox.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily J Amsden, BS

CONTACT

[email protected]

215-316-2343

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
Apr 30, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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