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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07830134
Status
Recruiting
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Conditions

  • Medulloblastoma, Childhood
  • Survivorship

Eligibility Criteria

Sex
ALL
Age
10 Years - 25 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Jul 26, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: DLPFC Neurofeedback Group
    Participants receive real-time fMRI neurofeedback targeting the dorsolateral prefrontal cortex (DLPFC) to train working memory-related brain activity.
  • Active Comparator: PAC Neurofeedback Group
    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.

Primary Outcome Measure

Enrollment Rate Among Approached Survivors (%) [ Time Frame: Assessed at 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Ranganatha Sitaram, ME, PhD
[email protected]
866-278-5833
Ranganatha Sitaram, ME, PhD (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN

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