St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Location status: Recruiting
Location contact
Ranganatha Sitaram, ME, PhD
CONTACT
Ranganatha Sitaram, ME, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07830134
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.
Interested in participating?
Request Info10 year–25 year
All sexes
Interventional
Not applicable
Memphis, Tennessee, 38105, United States
Location status: Recruiting
Ranganatha Sitaram, ME, PhD
CONTACT
Ranganatha Sitaram, ME, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Real time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity.
Real time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures.
Time frame: Assessed at 3 years
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.
Time frame: Assessed at 3 years
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.
Time frame: Assessed at 3 years
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.
Time frame: Assessed at 3 years
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.
Time frame: Assessed at 3 years
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.
Time frame: Assessed at 3 years
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.
Contact information is provided by the study sponsor or research team.
St. Jude Children's Research Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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