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.
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).
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).
Parallel
rt fMRI Neurofeedback (DLPFC)
BehavioralReal time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity.
rt fMRI Neurofeedback (PAC)
BehavioralReal time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures.
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.
Hemo-NFB Training Completion Rate Among Randomized Participants (%)
Percentage of randomized participants who complete at least 2 of the 3 scheduled Hemo-NFB training sessions, including N-back tasks, neurocognitive assessments, and side effects evaluations. A completion rate of 60% or greater will support the feasibility of the intervention.
Rate of Training-Related Side Effects Among Randomized Participants (%)
Percentage of randomized participants who experience neurofeedback training-related side effects, defined as a ≥200% increase from the pre-training assessment on at least 2 of the 3 neurofeedback training days. Side effects will be assessed using the Child Simulation Sickness Questionnaire (CSSQ), a 7-item measure of simulator-related symptoms across nausea, oculomotor symptoms (e.g., eye strain), and disorientation (e.g., dizziness). Each item is rated on a 3-point scale (0 = No, 1 = A little, 2 = A lot). A lower percentage of participants meeting the side-effect criterion indicates greater acceptability of the intervention.
Change in Bilateral DLPFC Modulation During fMRI Neurofeedback (% BOLD Signal Change, mean ± SD)
Bilateral DLPFC activity will be measured using the blood oxygenation level-dependent (BOLD) fMRI signal during neurofeedback training. For each neurofeedback run, DLPFC modulation will be quantified as the difference in BOLD activity between upregulation and rest/baseline conditions. Change in the DLPFC modulation index across neurofeedback runs will be used to assess participants' ability to learn to self-regulate DLPFC activity. Greater positive modulation indicates greater upregulation of DLPFC activity. Change in DLPFC activity will be summarized separately for the intervention and control groups. We will report 4 numbers: left DLPFC change (mean±SD) in intervention group, right DLPFC change (mean±SD) in intervention group, left DLPFC change (mean±SD) in control group, and right DLPFC change (mean±SD) in control group. Measured during fMRI neurofeedback training on Days 1 and 2.
Change in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) Score (mean ± SD)
The BRIEF is a parent questionnaire designed to assess everyday executive functioning. Executive functions include goal-directed behaviors, such as the ability to plan, organize, sustain performance, and change performance in response to feedback (10-15 minutes). We will report the change in the BRIEF Working Memory index from baseline to after day 3 of training. Measured at baseline on Day 1 before neurofeedback training and after completion of fNIRS neurofeedback training on Day 3.
Change in Age-Standardized Wechsler Working Memory Index Score (mean ± SD)
The Digit Span and Letter-Number Sequencing tasks from the age-appropriate WISC-V or WAIS-IV will be administered as measures of attention (Digit Span Forward) and working memory (Digit Span Backward; Letter-Number Sequencing). Forward-span tasks are considered measures of attention and immediate recall, whereas backward-span and sequencing tasks, which require reordering stimuli before responding, are regarded as measures of working memory (15 minutes). We will report the change in the Working Memory Index, a composite score consisting of Digit Span and Letter-Number Sequencing tasks, from baseline to after days 2 and 3 of training.
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