Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Part of paid clinical trials in Memphis, Tennessee.
- Sponsor
- St. Jude Children's Research Hospital
- Study ID
- NCT05947045
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 22 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cognitive training via iPad — OTHERParticipants will complete five sessions of the Cogmed training program on an iPad. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.
- Cognitive training via virtual reality — OTHERParticipants will complete five sessions of the Cogmed training program within virtual reality. Participants will complete sessions over the course of one to two weeks while on campus for radiotherapy. Each session will take place in the Psychology Clinic and consist of 15 to 20 minutes of Cogmed training.
Study Details
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.
Key Dates
- Start date
- Jun 22, 2023
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: IPad Cogmed TrainingThe investigator will be randomizing participants to complete Cogmed training on an iPad.
- Experimental: Virtual Reality Cogmed TrainingThe investigator will be randomizing participants to complete Cogmed training in Virtual Reality.
Primary Outcome Measure
Participation Rate [ Time Frame: After approach for enrollment, an average of 3 weeks after starting radiation therapy ]
Central Contacts
- Heather Conklin, PhD888-226-4343
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | 888-226-4343 |
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