Recruiting

Neurocognitive Assessment

Sponsor:

Washington University School of Medicine

Code:

NCT02559752

Conditions

Central Nervous System

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Interventions

NIH Toolbox Cognitive Battery

Study Details

Brief summary:

This study will explore neurocognitive performance in pediatric brain tumor patients receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline neurocognitive testing prior to the completion of the first week of radiation therapy along with follow-up testing 6-12 months after the completion of radiation and serial annual testing thereafter. With these data the investigators plan to evaluate the effects of PBRT on neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and radiation dose. Modeling studies have demonstrated that PBRT could improve neurocognitive outcomes, but there is a paucity of prospectively-collected patient data. The investigators are uniquely positioned to address this important question given the busy pediatric central nervous system (CNS) tumor service, the delivery of proton therapy at the S. Lee Kling Proton Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary research team with extensive experience into the late effects of therapy as it relates to neurocognition.

Conditions

Central Nervous System

Study ID

NCT02559752

Start date

Oct 13, 2015

Status verified date

Apr, 2026

Completion date

Apr 30, 2032

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm 1: NIH Toolbox Cognitive Battery testing

  • This study will use the NIH Toolbox Cognitive Battery computer testing software to investigate the cognitive outcomes in children with CNS tumors receiving PBRT.
  • Participants recruited for the study will complete one 45-minute testing session prior to the completion of the first week of radiation therapy.
  • They will then complete serial tests 6-12 months after the completion of PBRT and then yearly thereafter.

Interventions

NIH Toolbox Cognitive Battery

  • For ages 4 to 7 years, the NIH Toolbox Early Childhood Battery will be administered. This test includes the Picture Vocabulary, Flanker Inhibitory Control and Attention, Dimensional Change Card Sort, and Picture Sequence Memory measures to evaluate language, executive function, attention, and episodic memory, respectively.
  • For patients age 8 years or older, the administered battery will consist of the aforementioned tests in addition to Oral Reading Recognition, Pattern Comparison Processing Speed, and List Sort Working Memory tests. Results will include scores for each individual measure. In addition, each cognition battery provides composite scores, which allow for general interpretation/evaluation of overall cognitive functioning.

Primary outcome measure

  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients. [ Time Frame: At the completion of enrollment of all patients (estimated to be 9 years) ]
  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors [ Time Frame: 12 months ]
  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Stephanie Perkins, M.D.

314-747-4405sperkins@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stephanie Perkins, M.D.

314-747-4405sperkins@wustl.edu

Principal Investigator:

Stephanie Perkins, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-30.