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

St. Jude Children's Research Hospital40 enrolled

Overview

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.

Survivors of childhood medulloblastoma often have lasting problems with attention, working memory, and processing speed due to the tumor and its treatment (surgery, radiation, and chemotherapy). These changes commonly affect attention, working memory, and processing speed, which can interfere with school and daily activities Because current treatment options for cognitive problems are limited, researchers are studying new methods to support survivors. This study evaluates real time neuroimaging technologies such as real time functional magnetic resonance imaging (rt-fMRI) and real time functional near infrared spectroscopy (rt-fNIRS) 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. By watching this activity, participants may learn to "train" specific brain regions to work more effectively. Survivors aged 10-25 years who show signs of working memory difficulties will be invited to participate. They will be randomly assigned to receive neurofeedback from either the dorsolateral prefrontal cortex-a part of the brain important for working memory-or from the primary auditory cortex, which serves as a comparison condition. Both groups follow the same schedule and receive the same amount of training. Participants visit the study team three times over a period of 10 days to 3 weeks. During these visits, they take part in thinking and memory tests, perform working memory tasks inside the MRI scanner, and complete several short neurofeedback sessions. The study team will assess for any side effects, such as nausea or dizziness, before and after each scan. The study will assess early signs of benefit, such as whether neurofeedback helps participants increase activity in key brain areas and whether this relates to improvements in their thinking and memory test scores. The results will help guide a larger study in the future.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Enrollment Rate Among Approached Survivors (%)

The enrollment rate will be calculated as the percentage of eligible medulloblastoma survivors approached for study participation who provide consent/assent and enroll in the study. A rate of 60% or greater will indicate adequate participant interest and support study feasibility.