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Neurocognitive Assessment in Children with Brain Tumors Receiving Proton Beam Radiation Therapy

This study is looking at how proton beam radiation therapy (PBRT) affects the thinking and learning abilities (neurocognitive performance) of children aged 4 to 21 who have central nervous system (CNS) tumors. Researchers will use a computer-based test called the NIH Toolbox Cognitive Battery to measure these abilities. They want to see if PBRT improves neurocognitive outcomes, especially considering a child's age, tumor location, and radiation dose. The study aims to enroll 80 patients and is considered successful if at least 60% of eligible patients accept to participate and 80% of survivors complete follow-up testing at 12 months and 5 years. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 80 participants. It will collect information about neurocognitive performance over time.
What's involved
You would complete a computer-based neurocognitive test before starting radiation therapy, then again 6-12 months after radiation, and annually thereafter.
Compensation
Not stated in the trial record.
Follow-up
Participants will have follow-up testing for at least 5 years after radiation therapy.

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NCT02559752

Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy

Recruiting
Not specifiedAges 4–21Observational
Washington University School of Medicine
~80 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:NIH Toolbox Cognitive Battery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients.
Measured over At the completion of enrollment of all patients (estimated to be 9 years)
+2 more outcomes measured

Conditions

Central Nervous System

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Central Nervous System Neoplasm

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Stephanie Perkins, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Stephanie Perkins, M.D.
[email protected]
314-747-4405
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Eligibility criteria

Inclusion

Diagnosis of primary CNS tumor or diagnosis of metastatic disease to the CNS with an expected overall survival of \> 1 year. Any prior treatment (chemo, XRT, or surgery) is allowed.
Planning to receive PBRT to treat the CNS tumor. Patients who have already received PBRT for this disease may also be enrolled provided they completed the NIH Toolbox Cognitive Battery prior to the first week of radiation therapy.
Between 4 and 21 years of age (inclusive).
Life expectancy of at least one year.
Absence of visual impairment that would impede computer testing.
No secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer).
Able to understand and willing to sign IRB-approved written informed consent document (or signature of legally authorized representative).

What this trial measures

  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients.At the completion of enrollment of all patients (estimated to be 9 years)

    The acceptance rate will be a proportion of those who consent to participation over the total number of eligible and approached participants. The 60% acceptance rate is chosen because previous behavioral science intervention study participation in pediatric hematology and oncology ranges from 42% to 90%.

  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors12 months

    An implementation rate will be calculated by tracking the proportion of consented participants who complete at least two assessments in the first year of follow up. The primary length of time for implementation is in the first 12 months, but the rate of implementation will be tracked for up to five years for each participant. This is consistent with a two-staged assessment from Butler's remediation trial.

  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors5 years

    An implementation rate will be calculated by tracking the proportion of consented participants who complete at least two assessments in the first year of follow up. The primary length of time for implementation is in the first 12 months, but the rate of implementation will be tracked for up to five years for each participant. This is consistent with a two-staged assessment from Butler's remediation trial.