Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
NCT ID: NCT02747576
Last Updated: 2021-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2016-07-13
2018-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Medulloblastoma Group
Medulloblastoma survivors, 30 between the ages of 12-20 years and 30 between 21-30 years.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* Enrolled on the SJLIFE protocol as a community control.
* Between 12 and 30 years of age at time of enrollment.
* English speaking.
Exclusion Criteria
* 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.
* 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.
12 Years
30 Years
ALL
Yes
Sponsors
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St. Baldrick's Foundation
OTHER
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Tara M. Brinkman, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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FACES
Identifier Type: -
Identifier Source: org_study_id