Brain TumorNCT05947045
Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
A study testing Cognitive training via iPad and Cognitive training via virtual reality in people with Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Cognitive training via iPad and Cognitive training via virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2023to Mar 2027
- 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 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
888-226-4343, referralinfo@stjude.org
About this study
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:
- 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?
- Will cognitive training via virtual reality provide neurocognitive benefits?
- 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.
Read the detailed description
The objectives of this study are:
Primary Objective:
- To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.
Secondary Objectives:
- To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad.
- To evaluate patterns of cortical activation (oxygenated and deoxygenated hemoglobin responses) pre- and post- cognitive training in the virtual reality setting and on an iPad.
The investigators will use a randomized, single blind (psychology examiner), parallel group design (cognitive training via iPad versus virtual reality) to test hypotheses about behavioral and neurophysiological changes associated with cognitive training in childhood cancer survivors. The investigators will recruit patients who are being treated for a BT with radiotherapy. Patients will participate in study sessions in the Psychology Clinic during routine visits to St. Jude for radiotherapy. fNIRS studies will be conducted with participants randomized to both the virtual reality and iPad groups pre- and post- Cogmed training sessions. The time period between pre- and post-cognitive assessments will be 2 to 4 weeks for both virtual reality and iPad groups.
Participants will be enrolled until 30 patients initiating radiotherapy for a BT are evaluable, with approximately 20 randomized to the virtual reality group and 10 to the iPad group. The investigators expect to recruit and screen up to 45 patients to ascertain 30 eligible participants.
Enrollment and assessment will be completed approximately 18 months after the study begins. Imaging data will be processed approximately two years after the study begins, and study findings will be disseminated within three years after the study begins.
Data management and statistical analysis will be provided locally by the Department of Psychology, the Neuroimaging Division of Radiological Sciences and the Biostatistics Department at St. Jude Children's Research Hospital
- Conditions
- Brain Tumor
- Being tested
- Cognitive training via iPad, Cognitive training via virtual reality
- Keywords
- Radiotherapy, Brain tumor, Cognitive training, Virtual Reality, Working memory
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training via iPadOther
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 realityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IPad Cogmed Training | Active comparator | The investigator will be randomizing participants to complete Cogmed training on an iPad. Receives: Other: Cognitive training via iPad |
| Virtual Reality Cogmed Training | Experimental | The investigator will be randomizing participants to complete Cogmed training in Virtual Reality. Receives: Other: Cognitive training via virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation Rate
The participation rate of this study (i.e., how many patients agree to participate/how many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants.
Measured: After approach for enrollment, an average of 3 weeks after starting radiation therapy
Adherence
The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups.
Measured: At the completion of radiation therapy, an average of 6 weeks after enrollment
Side Effects
Summary statistics, including counts and percentages of side effects/cyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality.
Measured: At the completion of radiation therapy, an average of 6 weeks after enrollment
Secondary outcomes (2)
Neurobehavioral
To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad. The effect size of the change in cognitive outcomes is defined as the difference in group means/standard deviation (e.g., Cohen's d). The effect size will be calculated separately for change in cognitive outcomes for cognitive training in the virtual reality setting or on iPad. The effect size of the difference of the change between two groups will also be estimated.
Measured: After completion of post-training assessment, an average of 8 weeks after enrollment
Cerebral Hemodynamics
To evaluate patterns of cortical activation (oxygenated hemoglobin response) pre- and post- cognitive training on the iPad and in the virtual reality setting. The effects of VR and iPad based cognitive training will be assessed by n-back and grid-based spatial working memory tasks in conjunction with fNIRS brain imaging of the prefrontal cortex.
Measured: After completion of post-training assessment, an average of 8 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start22 Jun 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Heitzer, PhD, ABPP-CN, Principal investigator, St. Jude Children's Research HospitalHeather Conklin, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947045
- Sponsor's protocol ID
- COGVR
- Other IDs
- NCI-2023-03975
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
- ClinicalTrials.gov ID
- NCT05947045
- Acronym / sponsor ID
- COGVR
- Conditions
- Brain Tumor
- Keywords
- Radiotherapy, Brain tumor, Cognitive training, Virtual Reality, Working memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Jul 2023 (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.
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:
- 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?
- Will cognitive training via virtual reality provide neurocognitive benefits?
- 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.
Detailed description
The objectives of this study are:
Primary Objective:
- To estimate the participation rate, intervention adherence, and side effects of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors.
Secondary Objectives:
- To estimate the effect size of change in cognitive outcomes associated with cognitive training in the virtual reality setting relative to cognitive training on an iPad.
- To evaluate patterns of cortical activation (oxygenated and deoxygenated hemoglobin responses) pre- and post- cognitive training in the virtual reality setting and on an iPad.
The investigators will use a randomized, single blind (psychology examiner), parallel group design (cognitive training via iPad versus virtual reality) to test hypotheses about behavioral and neurophysiological changes associated with cognitive training in childhood cancer survivors. The investigators will recruit patients who are being treated for a BT with radiotherapy. Patients will participate in study sessions in the Psychology Clinic during routine visits to St. Jude for radiotherapy. fNIRS studies will be conducted with participants randomized to both the virtual reality and iPad groups pre- and post- Cogmed training sessions. The time period between pre- and post-cognitive assessments will be 2 to 4 weeks for both virtual reality and iPad groups.
Participants will be enrolled until 30 patients initiating radiotherapy for a BT are evaluable, with approximately 20 randomized to the virtual reality group and 10 to the iPad group. The investigators expect to recruit and screen up to 45 patients to ascertain 30 eligible participants.
Enrollment and assessment will be completed approximately 18 months after the study begins. Imaging data will be processed approximately two years after the study begins, and study findings will be disseminated within three years after the study begins.
Data management and statistical analysis will be provided locally by the Department of Psychology, the Neuroimaging Division of Radiological Sciences and the Biostatistics Department at St. Jude Children's Research Hospital
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPad Cogmed Training | Active comparator | Other: Cognitive training via iPadThe investigator will be randomizing participants to complete Cogmed training on an iPad. |
| Virtual Reality Cogmed Training | Experimental | Other: Cognitive training via virtual realityThe investigator will be randomizing participants to complete Cogmed training in Virtual Reality. |
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Cognitive training via iPadParticipants 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. | Other | IPad Cogmed Training |
| Cognitive training via virtual realityParticipants 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. | Other | Virtual Reality Cogmed Training |
Primary outcome
Participation Rate
Time frame: After approach for enrollment, an average of 3 weeks after starting radiation therapy
The participation rate of this study (i.e., how many patients agree to participate/how many patients are approached for participation) and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants.
Adherence
Time frame: At the completion of radiation therapy, an average of 6 weeks after enrollment
The completion of cognitive training sessions is defined as completion of four out of five planned sessions. The rate of completion of cognitive training sessions and its 90% Blyth-Still-Casella exact binomial confidence intervals will be estimated for all participants, and separately for virtual reality and iPad administration groups.
Side Effects
Time frame: At the completion of radiation therapy, an average of 6 weeks after enrollment
Summary statistics, including counts and percentages of side effects/cyber sickness symptoms will be provided at pre-, immediate-, and 1-hour post-cognitive training for participants completing training via the iPad or virtual reality.
2 secondary outcomes
Neurobehavioral
Time frame: After completion of post-training assessment, an average of 8 weeks after enrollment
Cerebral Hemodynamics
Time frame: After completion of post-training assessment, an average of 8 weeks after enrollment
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 17 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- St. Jude Brain Tumor StudiesLink 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.
Andrew Heitzer, PhD, ABPP-CN principal investigator
St. Jude Children's Research Hospital
Heather Conklin, 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 Cognitive training via iPad and Cognitive training via virtual reality in people with Brain Tumor, 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 5 inclusion and 5 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 17 Jun 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 Heather Conklin, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Rate (time frame: After approach for enrollment, an average of 3 weeks after starting radiation therapy). 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 17 Jun 2026.