Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Because the underlying mechanisms of these deficits are poorly understood, the investigators propose to examine social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity, including an established core neural network of face perception in MB survivors and healthy controls. By comparing these outcomes between survivors of MB and healthy controls, investigators seek to identify the areas of the brain that help individuals recognize emotions.

Primary Objective:

• To evaluate social cognition in adolescent and young adult survivors of pediatric medulloblastoma.

Secondary Objective:

• To examine indices of brain integrity and function and their association with facial affect recognition in survivors of pediatric medulloblastoma.

Study Overview

• Status: Completed
• Conditions: Medulloblastoma

Detailed Description

Comprehensive social-cognitive and behavioral data will be collected and structural and functional brain imaging will be completed in an attempt to determine if disruptions to brain integrity and function caused by prior treatment of medulloblastoma directly influence social-cognition and behavior in survivors. These outcomes will be compared between survivors and age-, gender-, and race-matched healthy community controls.

Participants who meet eligibility criteria and consent will undergo neurocognitive (intelligence, attention, memory, processing speed, motor, executive function, and visuospatial) and social cognitive evaluations (affect recognition, prosody, social memory, withdrawal/isolation, loneliness, social anxiety, visuospatial, and executive function). Functional magnetic resonance imaging (fMRI) will be completed during affect identification tasks to assess activation of the core face perception network. Magnetic resonance with diffusion tensor imaging (DTI) will be obtained to quantify water diffusion within white matter tracts to assess white matter integrity and its association with functional outcomes.

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medulloblastoma survivors enrolled in the St Jude Lifetime Cohort parent protocol will be recruited to complete comprehensive social-cognitive and neurocognitive evaluations as well as structural and functional brain imaging. Investigators will also recruit a comparison sample of healthy individuals matched on age, sex and race.

Description

Inclusion Criteria - Medulloblastoma Survivors:

• Enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
• Completed treatment for medulloblastoma at SJCRH.
• Infratentorial tumor location.
• Treated with craniospinal irradiation.
• ≥ 5 years post diagnosis.
• Between 12 and 30 years of age at time of enrollment.
• English speaking.

Inclusion Criteria - Controls:

• Enrolled on the SJLIFE protocol as a community control.
• Between 12 and 30 years of age at time of enrollment.
• English speaking.

Exclusion Criteria - Medulloblastoma Survivors:

• Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., down syndrome, autism).
• History of head injury associated with neurocognitive impairment.
• Diagnosis of a serious psychiatric condition associated with neurocognitive or social morbidities (e.g. schizophrenia).
• Currently pregnant (due to MRI studies).
• Implanted metal unsafe for MRI or medical device (i.e. pacemaker)
• Requires sedation to complete MRI.
• Legally blind or unaidable hearing loss.
• Treated for medulloblastoma <3 years of age
• Received re-irradiation to the brain.
• Completed SJLIFE HPP-19 (pilot study) at SJCRH.

Exclusion Criteria - Controls:

• No history of childhood cancer or cancer related therapy.
• First degree relative or direct friend of medulloblastoma participant.
• Diagnosis of a genetic disorder/neurodevelopmental condition associated with neurocognitive or social impairment (e.g., down syndrome, autism).
• History of head injury associated with neurocognitive impairment.
• Diagnosis of a serious psychiatric condition associated with neurocognitive or social morbidities (e.g. schizophrenia).
• Currently pregnant (due to MRI studies).
• Implanted metal unsafe for MRI or medical device (i.e. pacemaker).
• Requires sedation to complete MRI.
• Legally blind or unaidable hearing loss.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Medulloblastoma Group; Medulloblastoma survivors, 30 between the ages of 12-20 years and 30 between 21-30 years.
Control Group; Health comparison group frequency matched on age (30 between the ages of 12-20 years and 30 between 21-30 years), gender and race.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition)	Mean scores on measures of facial affect recognition will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.	Within two months of participant enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures	Means scores on measures of visual spatial processing and executive function will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.	Within two months of participant enrollment
Activation of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using fMRI analysis	Patterns of brain activation (i.e. hemodynamic responses) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.	Within six months of participant enrollment
White matter integrity between the nodes of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using DTI analysis	Indices of white matter integrity (e.g., radial diffusivity, axial diffusivity) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.	Within six months of participant enrollment

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: St. Baldrick's Foundation
• Investigators: Principal Investigator: Tara M. Brinkman, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2016
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Childhood Cancer Survivor; Social-cognition
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Medulloblastoma
• Other Study ID Numbers: FACES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No