Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

NCT02747576 | Completed

• 1 other identifier: FACES
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Medulloblastoma

Keywords

Childhood Cancer Survivor; Social-cognition; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition)

  Mean scores on measures of facial affect recognition will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.

  Within two months of participant enrollment

Secondary Outcomes (3)

• Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures

  Within two months of participant enrollment

• 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

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Medulloblastoma survivors enrolled in the St Jude Lifetime Cohort parent protocol will be recruited to complete comprehensive social-cognitive and neurocognitive evaluations as well as structural and functional brain imaging. Investigators will also recruit a comparison sample of healthy individuals matched on age, sex and race.

You may qualify if:

• 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.
• Enrolled on the SJLIFE protocol as a community control.
• Between 12 and 30 years of age at time of enrollment.
• English speaking.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• St. Baldrick's Foundation: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Medulloblastoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tara M. Brinkman, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 22, 2016
• Study Start: July 13, 2016
• Primary Completion: June 25, 2018
• Study Completion: August 31, 2018
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

US (1)