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

Conditions

• Central Nervous System

Eligibility Criteria

Sex

ALL

Age

4 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• NIH Toolbox Cognitive Battery — OTHER
  * 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.

Study Details

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.

Key Dates

Start date

Oct 13, 2015

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2032

Study Design

Enrollment

80 participants (estimated)

Arms

• Arm: 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.

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) ]

Central Contacts

• Stephanie Perkins, M.D.
  314-747-4405
  [email protected]
• Lindsey Brunt, BS
  314-362-6532
  [email protected]

Locations (1)

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