Medulloblastoma, ChildhoodNCT07830134
Cognitive Rehabilitation for Survivors of Childhood Medulloblastoma Using Real Time Hemodynamic Neurofeedback
A study testing rt fMRI Neurofeedback (DLPFC) and rt fMRI Neurofeedback (PAC) in people with Medulloblastoma, Childhood and Survivorship, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Medulloblastoma, Childhood, Survivorship
- What is being tested?
- rt fMRI Neurofeedback (DLPFC) and rt fMRI Neurofeedback (PAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2026to Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ranganatha Sitaram contact
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Ranganatha Sitaram, ME, PhD, 866-278-5833, referralinfo@stjude.org
Ranganatha Sitaram, ME, PhD
About this study
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.
Read more
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.
- Conditions
- Medulloblastoma, Childhood, Survivorship
- Being tested
- rt fMRI Neurofeedback (DLPFC), rt fMRI Neurofeedback (PAC)
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rt fMRI Neurofeedback (DLPFC)Behavioural
Real time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity.
rt fMRI Neurofeedback (PAC)Behavioural
Real time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC Neurofeedback Group | Experimental | Participants receive real-time fMRI neurofeedback targeting the dorsolateral prefrontal cortex (DLPFC) to train working memory-related brain activity. Receives: 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. Receives: Behavioral: rt fMRI Neurofeedback (PAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed at 3 years
Secondary outcomes (3)
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.
Measured: Assessed at 3 years
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.
Measured: Assessed at 3 years
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.
Measured: Assessed at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start26 Jul 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medulloblastoma, ChildhoodStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranganatha Sitaram, ME, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830134
- Sponsor's protocol ID
- NEUFEED
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation for Survivors of Childhood Medulloblastoma Using Real Time Hemodynamic Neurofeedback
- ClinicalTrials.gov ID
- NCT07830134
- Acronym / sponsor ID
- NEUFEED
- Conditions
- Medulloblastoma, Childhood, Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 26 Jul 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLPFC Neurofeedback Group | Experimental | Behavioral: rt fMRI Neurofeedback (DLPFC)Participants receive real-time fMRI neurofeedback targeting the dorsolateral prefrontal cortex (DLPFC) to train working memory-related brain activity. |
| PAC Neurofeedback Group | Active comparator | Behavioral: rt fMRI Neurofeedback (PAC)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. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rt fMRI Neurofeedback (DLPFC)Real time fMRI neurofeedback targeting the dorsolateral prefrontal cortex to train participants to increase DLPFC activity. | Behavioural | DLPFC Neurofeedback Group |
| rt fMRI Neurofeedback (PAC)Real time fMRI neurofeedback using the primary auditory cortex as a control region with identical procedures. | Behavioural | PAC Neurofeedback Group |
Primary outcome
Enrollment Rate Among Approached Survivors (%)
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.
Hemo-NFB Training Completion Rate Among Randomized Participants (%)
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.
Rate of Training-Related Side Effects Among Randomized Participants (%)
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.
3 secondary outcomes
Change in Bilateral DLPFC Modulation During fMRI Neurofeedback (% BOLD Signal Change, mean ± SD)
Time frame: Assessed at 3 years
Change in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) Score (mean ± SD)
Time frame: Assessed at 3 years
Change in Age-Standardized Wechsler Working Memory Index Score (mean ± SD)
Time frame: Assessed at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ranganatha Sitaram contact
Ranganatha Sitaram, ME, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rt fMRI Neurofeedback (DLPFC) and rt fMRI Neurofeedback (PAC) in people with Medulloblastoma, Childhood and Survivorship, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ranganatha Sitaram, ME, PhD (866-278-5833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate Among Approached Survivors (%) (time frame: Assessed at 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.