Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Completed

• Conditions: Medulloblastoma

• Registration Number: NCT02747576
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2016-07-13
• Primary Completion: 2018-06-25
• Study Completion: 2018-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States