ClinicalTrials.gg
RecruitingNCT07830134Updated Sep 23, 2026

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

An interventional study of rt fMRI Neurofeedback (DLPFC) and rt fMRI Neurofeedback (PAC) in Medulloblastoma, Childhood and Survivorship, sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
10 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Medulloblastoma by St. Jude Children's Research Hospital — 3 open to participants now, 7 under way, none of them phase 3. Medulloblastoma · St. Jude Children's Research Hospital.

Started
2026
with 1 other
No phase
Only one
of the 12
Registered
12th of 12
by date

Among the 12 studies in Medulloblastoma by St. Jude Children's Research Hospital, this one is one of 2 that started in 2026, is the only one with no phase, and was the 12th registered.

Medulloblastoma

317 studies on the registry are indexed under Medulloblastoma; 51 are open to participants now.

Browse Medulloblastoma studies →

Open to participants now

3 of the 12 studies in Medulloblastoma by St. Jude Children's Research Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 36 Medulloblastoma studies recruiting now, 4 (11%) set no upper age limit and 30 (83%) stop at 75 or younger; 33 take children under 18; 1 take healthy volunteers.

This study: 10 Years to 25 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Medulloblastoma by St. Jude Children's Research Hospital, or all of them as a file.
02

Study 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.
Read the detailed description

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.

03

Conditions studied

  • Medulloblastoma, Childhood
  • Survivorship

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04

Who can participate

Ages eligible
10 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • Pregnancy. The St. Jude IRB requires that a female participant of (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    DLPFC Neurofeedback Group

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

    Behavioral: rt fMRI Neurofeedback (DLPFC)

  • 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.

    Behavioral: rt fMRI Neurofeedback (PAC)

Interventions

  • Behavioralrt fMRI Neurofeedback (DLPFC)

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

  • Behavioralrt fMRI Neurofeedback (PAC)

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Assessed at 3 years

  2. 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.

    Time frame: Assessed at 3 years

  3. 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.

    Time frame: Assessed at 3 years

Secondary outcomes

  1. 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.

    Time frame: Assessed at 3 years

  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.

    Time frame: Assessed at 3 years

  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.

    Time frame: Assessed at 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Dec 2029, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartActual
Jul 26, 2026
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2033
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07830134
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Jul 26, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2033 (estimated)
Last update
Sep 23, 2026

Study contacts

Ranganatha Sitaram, ME, PhD
Contact
referralinfo@stjude.org
866-278-5833
Ranganatha Sitaram
Contact
Ranganatha Sitaram, ME, PhD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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