Recruiting

Cognitive Training

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05947045

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 8 - 22

Healthy Volunteers: Not accepted

Interventions

Cognitive training via iPad

Cognitive training via virtual reality

Study Details

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.

Conditions

Brain Tumor

Study ID

NCT05947045

Start date

Jun 22, 2023

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 22

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: IPad Cogmed Training

The investigator will be randomizing participants to complete Cogmed training on an iPad.

experimental: Virtual Reality Cogmed Training

The investigator will be randomizing participants to complete Cogmed training in Virtual Reality.

Interventions

Cognitive training via iPad

Participants 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

Participants 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.

Primary outcome measure

  • Participation Rate [ Time Frame: After approach for enrollment, an average of 3 weeks after starting radiation therapy ]
  • Adherence [ Time Frame: At the completion of radiation therapy, an average of 6 weeks after enrollment ]
  • Side Effects [ Time Frame: At the completion of radiation therapy, an average of 6 weeks after enrollment ]

Central Contacts and Locations

Central contacts

Heather Conklin, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Radiotherapy
  • Brain tumor
  • Cognitive training
  • Virtual Reality
  • Working memory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-17.