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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive training can assist children with brain tumors during radiotherapy sessions. Researchers are testing two methods: cognitive training via iPad and cognitive training via virtual reality, to determine which is more effective and accepted by participants. The goal is to discover if these methods can enhance brain function and quality of life for children undergoing treatment. Children who are beginning radiotherapy for a brain tumor and speak English or Spanish may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve treatment experiences for children.

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 prior data suggests that cognitive training via iPad or virtual reality is safe for children undergoing radiotherapy for brain tumors?

Research shows that both iPad-based and virtual reality (VR) cognitive training are generally easy for participants to handle.

For iPad cognitive training, studies with children who have brain tumors have shown positive outcomes. These digital exercises have helped improve thinking skills and abilities like planning and focusing. These studies have not reported major negative side effects.

Similarly, VR-based cognitive training has shown promise. Research suggests that VR not only helps improve thinking skills but also boosts mood, reducing symptoms like depression. Users have found VR practical and easy to use without major side effects.

Both methods seem safe, with participants generally managing them well. This suggests that using either digital platform for cognitive training is unlikely to cause harm, making them good options for further study in children receiving radiotherapy for brain tumors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative ways to boost cognitive function in brain cancer patients. Unlike traditional cognitive therapies, which might rely on paper-based exercises or in-person sessions, these treatments use digital platforms like iPads and virtual reality. The iPad Cogmed Training provides a portable and accessible way to engage patients in cognitive exercises anywhere. Meanwhile, Virtual Reality Cogmed Training immerses patients in a 3D environment, potentially enhancing engagement and motivation. These methods could revolutionize how cognitive rehabilitation is delivered, making it more engaging and adaptable to individual needs.

What evidence suggests that this trial's cognitive training treatments could be effective for brain cancer?

Research shows that using an iPad for brain exercises can help children with brain tumors think more clearly and manage tasks better. One study found that digital activities improved memory and overall mental health. In this trial, participants may receive Cognitive Training via iPad, which has shown promise in boosting brain abilities.

Studies have found that virtual reality (VR) training helps improve focus and short-term memory. VR programs have been beneficial in addressing thinking problems in patients with brain tumors. Participants in this trial may also receive Cognitive Training via Virtual Reality, which could improve the quality of life for children receiving cancer treatment. This trial evaluates both iPad and VR training methods for their potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Heather Conklin, PhD

Principal Investigator

St. Jude Children's Research Hospital

Andrew Heitzer, PhD, ABPP-CN

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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 am willing to participate in Cogmed training.

Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines

Exclusion Criteria

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.

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])

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Radiation Therapy

Participants undergo radiotherapy for brain tumors

6 weeks

Routine visits to St. Jude for radiotherapy

Cognitive Training

Participants receive cognitive training via iPad or virtual reality

2-4 weeks

Pre- and post-intervention cognitive testing and exams

Follow-up

Participants are monitored for safety and effectiveness after cognitive training

2 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

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Computer-Based Cognitive Training in Children with Primary ... Results: Overall, nine studies were included; 152 patients (67.8% males) with brain tumours underwent a digital intervention. The mean age at diagnosis and the ...

2. nature.com nature.com/articles/s41523-024-00694-8

Computerized cognitive training improves ... In this prospective pilot study, web-based cognitive training was efficacious in improving overall cognitive performance and executive function.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000589

Web-based cognitive interventions on subjective ... This review demonstrated that web-based cognitive interventions optimized SCI and overall psychosocial and emotional statuses for the cancer survivors.

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A randomized controlled trial of a telehealth group cognitive ... LaTCH-BRAINS, a cognitive rehabilitation program, improved memory outcomes in primary brain tumor. High- and low-grade brain tumor survivors benefited.

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HOBSCOTCH-CA (HOme-Based Self-management and ... The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05570604

Computerized Cognitive Training in Breast Cancer Survivors The goal of this translational research study is to determine the feasibility, satisfaction and preliminary efficacy of cognitive training delivered in the home ...