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Not yet recruitingNCT07558473Updated Aug 7, 2026

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

An interventional study of Online computerized cognitive training intervention focused on processing speed. in Brain Tumor, Pediatric, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 5 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
5 Years to 25 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Brain Tumor, Pediatric

Keywords

  • Brain Tumor
  • Pediatric
  • Pediatric Brain Tumor
  • Cognitive Intervention
  • Intervention
  • Oncology
  • Cancer
03

Who can participate

Ages eligible
5 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Significant visual, hearing, motor, or cognitive impairment that precludes participation in computerized cognitive training program;
  2. Acute medical status (e.g., significant risk for mortality within 3-months of diagnosis).
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Cognitive Intervention

    Computerized cognitive training program focused on processing speed.

    Behavioral: Online computerized cognitive training intervention focused on processing speed.

Interventions

  • BehavioralOnline computerized cognitive training intervention focused on processing speed.

    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.

05

What researchers measure

Primary outcomes

  1. Feasibility - Enrollment

    Study enrollment rate.

    Time frame: Up to 5 years after diagnosis.

  2. Feasibility - Participant Retention

    Number of participants who complete the computerized brain training program.

    Time frame: 8 weeks

  3. Feasibility - Intervention Adherence

    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.

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

  4. Feasibility - Total Intervention Time

    Total time spent completing the cognitive training program exercises.

    Time frame: 8 weeks

  5. Acceptability

    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.

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

Secondary outcomes

  1. Cognitive Training Task-Based Performance

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

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

  2. Processing Speed

    Changes in processing speed as measured by the NIH toolbox.

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

  3. Attention

    Changes in attention as measured by the NIH toolbox.

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

  4. Working Memory

    Changes in working memory as measured by the NIH toolbox.

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

06

Study locations

1 site
  • Kennedy Krieger Institute
    Baltimore, Maryland 21205, United States
    • Emily J Amsden, BS · Contact · amsden@kennedykriger.org · 215-316-2343
    • Rachel K Peterson, PhD · Principal investigator
07

References and documents

Publications

  • Meneses K, Benz R, Bail JR, Vo JB, Triebel K, Fazeli P, Frank J, Vance DE. Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. Breast Cancer Res Treat. 2018 Feb;168(1):259-267. doi: 10.1007/s10549-017-4564-2. Epub 2017 Nov 11. PubMed 29128897 ↗
  • Maeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y. PubMed 36746805 ↗
  • Areklett EW, Hagen BI, Stubberud J, Fagereng E, Andersson S, Lindemann K. Digital goal management training for cognitive impairment in cervical cancer survivors-a randomized comparison study. J Cancer Surviv. 2026 Jun;20(3):978-989. doi: 10.1007/s11764-024-01701-4. Epub 2024 Nov 22. PubMed 39576570 ↗
  • Jacola LM, Peterson RK, Oswald-McCloskey KA, Sekely A, Mabbott DJ, Edelstein K. Neuropsychological function in childhood cancer patients and adult survivors of childhood cancer. J Clin Exp Neuropsychol. 2025 Oct;47(8):788-805. doi: 10.1080/13803395.2025.2521018. Epub 2025 Jul 9. PubMed 40635330 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07558473
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Jul 30, 2026 (estimated)
Primary completion
Jul 30, 2031 (estimated)
Completion
Apr 1, 2033 (estimated)
Last update
Aug 7, 2026

Study contacts

Emily J Amsden, BS
Contact
amsden@kennedykrieger.org
215-316-2343
Rachel K Peterson, PhD
principal investigator · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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