Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Sponsor
St. Jude Children's Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02747576
Collaborator
St. Baldrick's Foundation (Other)
137
1
25.6
5.4

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    137 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
    Actual Study Start Date :
    Jul 13, 2016
    Actual Primary Completion Date :
    Jun 25, 2018
    Actual Study Completion Date :
    Aug 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Jude Children's Research Hospital Memphis Tennessee United States 38105

    Sponsors and Collaborators

    • St. Jude Children's Research Hospital
    • St. Baldrick's Foundation

    Investigators

    • Principal Investigator: Tara M. Brinkman, PhD, St. Jude Children's Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    St. Jude Children's Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02747576
    Other Study ID Numbers:
    • FACES
    First Posted:
    Apr 22, 2016
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by St. Jude Children's Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021