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Cognitive Rehabilitation for Survivors of Childhood Medulloblastoma Using Real Time Hemodynamic Neurofeedback

Sponsor: St. Jude Children's Research Hospital • ClinicalTrials.gov ID: NCT07830134

Registry updated: 2026-09-23

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Description

This study will evaluate a new way to help childhood medulloblastoma survivors improve their thinking and memory skills. Many survivors experience long term challenges with attention and working memory because of the tumor and its treatments. The study uses real time neuroimaging technologies such as real time functional magnetic resonance imaging (rt-fMRI) and real time functional near infrared spectroscopy (rt-fNIRS) make it possible to monitor and display a participant's brain activity as it occurs. Neurofeedback uses this activity to provide individuals with immediate visual information about how specific brain regions are functioning, potentially enabling them to learn strategies to modulate or improve brain activity linked to thinking skills. Participants are randomly assigned to one of two groups. One group receives feedback from a brain area involved in working memory, and the other receives feedback from a different brain region as a comparison. Over three visits, participants complete brain scans, neurofeedback sessions, and thinking and memory tests. The main goal is to see if this type of brain training is practical, safe, and comfortable for survivors. The study also looks at whether the training may help improve brain activity and working memory performance. Primary Objective(s): • To evaluate the feasibility of real time Hemo-NFB neurofeedback training in medulloblastoma survivors. Secondary Objective(s): • To estimate the initial efficacy of Hemo-NFB neurofeedback to up-regulate the activity of the dorsolateral prefrontal cortex (DLPFC) and improve WM performance.

Interventions

rt fMRI Neurofeedback (DLPFC) (Behavioral)
Real time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity.
rt fMRI Neurofeedback (PAC) (Behavioral)
Real time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures.

Eligibility criteria

Inclusion Criteria: * Age ≥ 10 and ≤ 25 years at the time of enrollment. * English as a primary language. * Current St. Jude participants who received treatment for medulloblastoma with upfront craniospinal radiotherapy (proton or photon), inclusive of SJMB12 participants and those treated as per SJMB12 at least 2 years from completion of treatment of their medulloblastoma. * Demonstrate working memory impairment based on age-appropriate questionnaire electronically administered pre-enrollment. Specifically, scores \>57 on the Working Memory Index of the BRIEF (places the individual in the top 25% of people who have difficulty with working memory tasks). Exclusion Criteria: * History of seizures, on or off antiepileptic drugs, in the past 3 months. * A premorbid history of significant neurological disease, including stroke or head injury with loss of consciousness. * A psychiatric condition that would preclude or take precedence over study participation (e.g., active psychosis, suicidal ideation). * Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis). * IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology (NOPP). * Metal or surgical implants that would prevent MRI scanning. * Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent. * Pregnancy. The St. Jude IRB requires that a female participant of childbearing potential (generally \>10 yrs. old) must have a negative pregnancy test as a condition of clinical research eligibility. * Permanent orthodontic retainers or braces-shunt, anything else that would not be a safety risk but would impact image quality.

Conditions

Medulloblastoma, Childhood Survivorship

Locations

St. Jude Children's Research Hospital — Memphis, Tennessee, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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