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Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02747576
Enrollment
137
Registered
2016-04-22
Start date
2016-07-13
Completion date
2018-08-31
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medulloblastoma

Keywords

Childhood Cancer Survivor, Social-cognition, Healthy Volunteers

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.

Interventions

None listed

Sponsors

St. Baldrick's Foundation
CollaboratorOTHER
St. Jude Children's Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 30 Years
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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measuresWithin two months of participant enrollmentMeans 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 analysisWithin six months of participant enrollmentPatterns 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 analysisWithin six months of participant enrollmentIndices 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026