Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

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Disease Information

Descriptive Information
Brief Title † Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
Official Title † Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
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 Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition)
Secondary Outcome Measure † Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures
Condition † Medulloblastoma
Intervention †
Study Arms / Comparison Groups Medulloblastoma Group Medulloblastoma survivors, 30 between the ages of 12-18 years and 30 between 19-30 years. Control Group Health comparison group frequency matched on age (30 between the ages of 12-18 years and 30 between 19-30 years), gender and race.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 120
Start Date † July 13, 2016
Completion Date January 31, 2019
Primary Completion Date June 30, 2018
Eligibility Criteria † 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
Gender All
Ages 12 Years - 30 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Tara M. Brinkman, PhD, 866-278-5833,
Location Countries † United States
Administrative Information
NCT ID † NCT02747576
Organization ID FACES
Secondary IDs ††
Responsible Party Sponsor
Study 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
Information Provided By
Verification Date October 2016
First Received Date † April 13, 2016
Last Updated Date March 31, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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