Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Medulloblastoma Clinical Trial

Official title:

Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747576
• Other study ID #: FACES
• Status: Completed
• Start date: July 13, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2021
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 31, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medulloblastoma

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	St. Baldrick's Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures	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.	Within two months of participant enrollment
Secondary	Activation of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using fMRI analysis	Patterns of brain activation (i.e. hemodynamic responses) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.	Within six months of participant enrollment
Secondary	White matter integrity between the nodes of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using DTI analysis	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.	Within six months of participant enrollment

External Links

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