NCT05947045 Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
| NCT ID | NCT05947045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-06-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2023-06-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are: 1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects? 2. Will cognitive training via virtual reality provide neurocognitive benefits? 3. Will there be predictable changes in brain activity as measured by neuroimaging? Findings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.
Eligibility Criteria
Inclusion Criteria: * Initiating radiotherapy for a BT * Between 8-22 years of age at the time of enrollment * English or Spanish as the primary language * Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines * Participant willing to take part in required aspects of Cogmed training Exclusion Criteria: * Significant impairment in global intellectual functioning (estimated or full scale IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols or as part of the New Oncology Program in Psychology \[NOPP\]) * History of significant neurological disease preceding BT diagnosis including stroke or head injury with loss of consciousness * Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, inadequate balance to sit or stand unassisted to complete cognitive training) * Psychiatric condition that would preclude or take precedence over study participation (e.g. active psychosis, suicidal ideation) * Need for general anesthesia during radiation therapy (note: can participate if only sedated for simulation/planning but not daily treatment)
Contact & Investigator
Andrew Heitzer, PhD, ABPP-CN
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT05947045 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 22 Years, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05947045 currently recruiting?
Yes, NCT05947045 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT05947045 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT05947045 clinical trial?
NCT05947045 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Andrew Heitzer, PhD, ABPP-CN at St. Jude Children's Research Hospital. The trial plans to enroll 45 participants.