Cognitive training with real-time brain feedback for childhood medulloblastoma survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Survivors of childhood medulloblastoma often have lasting cognitive difficulties, including attention and working memory challenges. The study uses real-time brain imaging to monitor activity and provide neurofeedback during training sessions. Participants are randomized to feedback from a working-memory brain region (dorsolateral prefrontal cortex) or from a control region (primary auditory cortex) across three visits. The goal is to see if targeted neurofeedback can help improve cognitive functions used in school and daily life.

Why it matters

Who can join: the full rules

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:

* 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.

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Ranganatha Sitaram, ME, PhD — St. Jude Children's Research Hospital
• Study coordinator: Ranganatha Sitaram, ME, PhD
• Email: referralinfo@stjude.org
• Phone: 866-278-5833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.