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

NCT07830134 | Recruiting

• 1 other identifier: NEUFEED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medulloblastoma, Childhood; Survivorship

Outcome Measures

Primary Outcomes (3)

• 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.

  Assessed at 3 years

• 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.

  Assessed at 3 years

• 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.

  Assessed at 3 years

Secondary Outcomes (3)

• Change in Bilateral DLPFC Modulation During fMRI Neurofeedback (% BOLD Signal Change, mean ± SD)

  Assessed at 3 years

• Change in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) Score (mean ± SD)

  Assessed at 3 years

• Change in Age-Standardized Wechsler Working Memory Index Score (mean ± SD)

  Assessed at 3 years

Study Arms (2)

DLPFC Neurofeedback Group

EXPERIMENTAL

Participants receive real-time fMRI neurofeedback targeting the dorsolateral prefrontal cortex (DLPFC) to train working memory-related brain activity.

Behavioral: rt fMRI Neurofeedback (DLPFC)

PAC Neurofeedback Group

ACTIVE COMPARATOR

Participants receive real-time fMRI neurofeedback targeting the primary auditory cortex (PAC). This serves as an active control to account for non-specific effects of neurofeedback and scanner exposure.

Behavioral: rt fMRI Neurofeedback (PAC)

Interventions

rt fMRI Neurofeedback (DLPFC) BEHAVIORAL

Real time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity.

DLPFC Neurofeedback Group

rt fMRI Neurofeedback (PAC) BEHAVIORAL

Real time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures.

PAC Neurofeedback Group

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Medulloblastoma

Interventions

Chromosomes, Artificial, P1 Bacteriophage

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chromosomes, Artificial; Chromosomes; Genetic Structures; Genetic Phenomena; Genetic Vectors

Study Officials

• Ranganatha Sitaram, ME, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranganatha Sitaram, ME, PhD

CONTACT

866-278-5833; referralinfo@stjude.org

Ranganatha Sitaram

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this double-blinded, randomized study, participants will be stratified by age (10 - \<17y and 18 -\<25y) and within each stratum, subjects will be randomized 2:1 to receive intervention or control.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: July 26, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2033
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

US (1)