Cognitive Training for Brain Cancer

Overseen By Heather Conklin, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Low IQ, Neurological disease, Sensory/motor impairment, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Cognitive Training for Brain Cancer is an effective treatment?

The available research shows that cognitive training, especially using virtual reality (VR), can be beneficial for patients with brain tumors and other cognitive impairments. For example, VR training helps improve cognitive function by providing a stimulating environment that encourages focus and attention. Additionally, computer-assisted cognitive training has been shown to be effective in neurological rehabilitation, particularly for improving attention. While more research is needed specifically for brain cancer, these findings suggest that cognitive training can be a valuable part of treatment. ^{1 2 3 4 5}

What safety data exists for cognitive training in brain cancer?

The studies reviewed indicate that cognitive training using virtual reality and computer-assisted methods has been explored in various contexts, such as mild cognitive impairment, dementia, and traumatic brain injury. These studies suggest that such interventions are feasible and usable, with positive effects on cognitive function and mood. However, specific safety data for brain cancer patients is not directly addressed in these studies. The general implication is that these methods are considered safe and beneficial in related cognitive conditions, but further research would be needed to confirm safety specifically for brain cancer patients. ^{2 5 6 7 8}

Is Cognitive training via iPad and virtual reality a promising treatment for brain cancer?

Yes, cognitive training using virtual reality and computer-based methods is promising. It can help improve attention, memory, and mood by providing a fun and engaging way to train the brain. Virtual reality creates a rich and immersive environment that helps patients focus better, making it a valuable tool for cognitive rehabilitation. ^{1 2 5 9 10}

Research Team

Andrew Heitzer, PhD, ABPP-CN

Principal Investigator

St. Jude Children's Research Hospital

Heather Conklin, PhD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children aged 8-22 undergoing radiotherapy for brain tumors, who speak English or Spanish. They and a parent must agree to participate and follow the study's procedures. It excludes those with an IQ < 70, severe psychiatric conditions, major sensory/motor impairments that affect testing, significant neurological history before their tumor diagnosis, or need for general anesthesia during treatment.

Inclusion Criteria

I am between 8 and 22 years old.

I primarily speak English or Spanish.

I am willing to participate in 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])

I have had a significant brain-related condition like a stroke or severe head injury before my brain tumor diagnosis.

I do not have any major physical or sensory issues that would stop me from completing cognitive tests.

Treatment Details

Interventions

• Cognitive training via iPad
• Cognitive training via virtual reality

Trial Overview The study tests cognitive training using either an iPad or virtual reality (VR) to see if VR is feasible and acceptable in this setting. Children will be randomly assigned to one of these methods and undergo cognitive tests plus brain activity exams before and after the intervention to assess potential neurocognitive benefits.

Participant Groups

Group I: Virtual Reality Cogmed Training Experimental Treatment 1 Intervention

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

Group II: IPad Cogmed Training Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

In a study of 38 brain tumor patients, those who underwent virtual reality (VR) training alongside computer-based cognitive rehabilitation showed significant improvements in various cognitive tests compared to those who only received the computer program.

The VR group demonstrated better results in specific cognitive areas, such as visual and auditory attention, memory span, and processing speed, suggesting that VR training can enhance cognitive recovery in brain tumor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of virtual reality on cognitive dysfunction in patients with brain tumor. Yang, S., Chun, MH., Son, YR.[2022]

Computer-assisted cognitive training has been shown to be an effective tool in neurological rehabilitation, particularly for patients with attention deficits, as it allows for precise stimulus representation and reaction time measures.

This type of training is most beneficial when integrated into a comprehensive therapeutic framework, enhancing the overall rehabilitation process and ensuring sufficient therapeutic intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. Reuter, BM., Schönle, PW.[2006]

The Human Experience Modeler (HEM) is a mixed-reality system designed for cognitive rehabilitation, providing a controlled environment that enhances natural cuing and contextual learning for patients with cognitive impairments.

A pilot study demonstrated the system's potential effectiveness in helping a participant with working memory issues following an aneurysm, suggesting that this innovative approach could improve cognitive retraining outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Experience Modeler: context-driven cognitive retraining to facilitate transfer of learning. Fidopiastis, CM., Stapleton, CB., Whiteside, JD., et al.[2019]

A systematic review of three studies involving 130 older adults with Mild Cognitive Impairment (MCI) suggests that Virtual Reality-based cognitive rehabilitation therapy (VR-CRT) is at least as effective as traditional cognitive rehabilitation therapy (CRT) in improving cognitive function and executive function.

Despite the promising results, the limited number of studies and small sample sizes raise concerns about the reliability of the findings, highlighting the need for more rigorous research and standardized VR protocols to better assess the efficacy of VR-CRT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Tortora, C., Di Crosta, A., La Malva, P., et al.[2023]

A study involving 10 physiatrists, 6 occupational therapists, and 11 patients with mild cognitive impairment and mild dementia found that a fully immersive virtual reality (VR) cognitive training program was feasible and well-received, with high satisfaction scores from both therapists (5.75) and patients (5.64).

While the training did not show statistically significant improvements in response time or finger tapping, there was a noted decrease in response time after the session, suggesting a potential temporary increase in attention, and importantly, no participants experienced any adverse effects like motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. Yun, SJ., Kang, MG., Yang, D., et al.[2020]

The virtual reality examination (VR-E) developed for assessing cognitive function showed promising results, correlating well with established tests like the MMSE and MoCA-J in a study of 77 participants aged around 75 years.

VR-E effectively distinguished between different levels of cognitive impairment, with a completion time of about 5 minutes, making it a less burdensome option for detecting mild cognitive changes, although some participants faced challenges due to understanding or health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A cognitive function test utilizing eye tracking technology in virtual reality]. Mizukami, K., Taguchi, M., Kouketsu, T., et al.[2023]

Virtual-reality-based cognitive training (VRCT) significantly improved cognitive function in older adults with mild cognitive impairment (MCI), as evidenced by better scores on the Mini-Mental State Examination (MMSE) after 24 sessions of training.

Both VRCT and exercise interventions enhanced cognitive and physical health, with exercise also improving handgrip strength, indicating that both methods are beneficial for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. Yang, JG., Thapa, N., Park, HJ., et al.[2023]

A case study of a 15-year-old boy with severe traumatic brain injury (TBI) showed that using an immersive virtual environment (CAREN) for cognitive rehabilitation led to significant improvements in attention, visuo-executive processes, emotional awareness, and balance compared to traditional methods.

The study suggests that cognitive training through immersive Virtual Reality can be a safe and effective approach to enhance cognitive recovery in adolescents with TBI, highlighting its potential as a valuable rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation using immersive virtual reality at young age: A case report on traumatic brain injury. De Luca, R., Portaro, S., Le Cause, M., et al.[2021]

A systematic review of 17 studies involving 226 individuals with Autism Spectrum Disorder (ASD) found that virtual reality-based interventions significantly improved cognitive functions such as attention, task learning, and executive functioning.

Despite the positive effects, challenges like the high cost of technology, device comfort, and potential side effects highlight the need for further research to ensure the long-term efficacy and safety of these virtual reality approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in people with autism spectrum disorder: a systematic review of emerging virtual reality-based approaches. Shahmoradi, L., Rezayi, S.[2022]

A systematic review of nine studies, including four randomized clinical trials, found that virtual reality (VR) training can significantly improve cognitive functions such as memory and executive function in patients with traumatic brain injury (TBI).

The effective VR treatment protocol involved 10-12 sessions lasting 20-40 minutes each, conducted 2-4 times per week, although the evidence for improvements in attention was weaker.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. Alashram, AR., Annino, G., Padua, E., et al.[2019]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of virtual reality on cognitive dysfunction in patients with brain tumor. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Human Experience Modeler: context-driven cognitive retraining to facilitate transfer of learning. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Cognitive Training Using Fully Immersive, Enriched Environment Virtual Reality for Patients With Mild Cognitive Impairment and Mild Dementia: Feasibility and Usability Study. [2020]

6. Japan pubmed.ncbi.nlm.nih.gov

[A cognitive function test utilizing eye tracking technology in virtual reality]. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation using immersive virtual reality at young age: A case report on traumatic brain injury. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in people with autism spectrum disorder: a systematic review of emerging virtual reality-based approaches. [2022]

10. Scotland pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. [2019]