VR Brain Training for Traumatic Brain Injury

Overseen By Duje Tadin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Under 18, Neurologic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether brain training using Virtual Reality (VR) can enhance brain function in individuals with and without traumatic brain injuries (TBI). Participants will train using either regular computer screens or VR setups. The trial seeks adults over 18, focusing on college athletes who have experienced a mild TBI, such as a concussion, within the past two weeks, and older adults over 65 without brain disorders. Those who enjoy tech and meet these criteria might be a good match. As an unphased trial, this study provides a unique opportunity to explore innovative brain training methods and contribute to advancing research in cognitive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this VR brain training is safe for traumatic brain injury patients?

Research has shown that virtual reality (VR) training is generally safe for people with traumatic brain injury (TBI). In several studies, patients using VR demonstrated positive results, with improvements in cognitive and motor abilities. Although detailed safety information isn't always available, VR is often considered a safe tool for rehabilitation.

No specific safety issues have been reported in the studies reviewed. VR training is well-received and seen as promising for helping TBI patients. Consequently, many researchers are eager to explore its potential further. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help people with traumatic brain injuries (TBI) recover cognitive function. Traditional treatments for TBI often involve physical therapy and medication, but this study is looking at virtual reality (VR) training as a new method. VR training immerses participants in a 3D environment, potentially making the rehabilitation process more engaging and effective. Additionally, the trial compares VR training with conventional computer screen training to see which method might provide better results. By pushing the boundaries of how we approach TBI recovery, this trial could open up new possibilities for enhancing brain health and rehabilitation outcomes.

What evidence suggests that this trial's treatments could be effective for traumatic brain injury?

Research has shown that virtual reality (VR) training, one of the methods tested in this trial, can aid people with traumatic brain injury (TBI). VR training enhances skills such as attention and coordination. Studies have found that TBI patients benefit from VR when it targets specific brain functions. Similarly, another method tested in this trial is computer screen training, which can also be helpful. It has been shown to boost memory and other cognitive skills in TBI patients, though some evidence is less strong. Both methods can be beneficial, but VR might offer a more engaging and immersive experience. ^{3 6 7 8 9}

Who Is on the Research Team?

Duje Tadin, PhD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with good hearing and vision, who don't play action or VR video games. It includes healthy young adults, older adults without neurological issues, and college athletes recently diagnosed with mild traumatic brain injury (concussion).

Inclusion Criteria

Assigned to one of four groups: Control Group training in VR, Control Group training on a 2D display, Older Adult Group without dementia training in VR, College Athletes with mild TBI Group training in VR

Non-action video game player and non-VR game player

I am between 18 and 35 years old and do not have any neurological or vascular disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo brain training using Virtual Reality or on a computer screen

6 weeks

Follow-up

Participants are monitored for cognitive and perceptual improvements after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computer Screen Training
• Virtual Reality Training

Trial Overview

The study compares the effectiveness of brain training exercises when done in Virtual Reality versus on a computer screen. It aims to see if VR can enhance cognitive rehabilitation after a traumatic brain injury.

How Is the Trial Designed?

Group I: Older Adult Group Experimental Treatment 1 Intervention

Older Adults over the age of 65 who will be training in Virtual Reality

Group II: Control in VR Experimental Treatment 1 Intervention

Adults ages 18 to 35 who will be training in Virtual Reality.

Group III: Control Non-VR Experimental Treatment 1 Intervention

Adults ages 18 to 35 who will be training on a computer screen.

Group IV: College Athletes with TBI Group Experimental Treatment 1 Intervention

Adults ages 18 to 35 with mild TBI who will be training in Virtual Reality

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

NeuroTrainer

Industry Sponsor

Trials

2

Recruited

240+

Neurotrainer

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

A 4-week program of nonimmersive virtual reality (VR) exercise significantly improved cognitive functions, such as attention and memory, in 13 adults with traumatic brain injury (TBI) compared to control groups.

A single session of VR exercise also led to notable improvements in reaction and movement times, suggesting that even short bouts of exercise in a virtual environment can enhance cognitive performance in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognitive function after brain injury: the use of exercise and virtual reality. Grealy, MA., Johnson, DA., Rushton, SK.[2022]

Individuals with disabilities can effectively learn motor skills in virtual reality environments, which can translate to real-world tasks and even improve untrained skills.

Clinical studies indicate that virtual reality training may offer advantages over traditional motor learning methods, with no reported cases of cybersickness in patients using VR for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual environments for motor rehabilitation: review. Holden, MK.[2022]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

Virtual reality (VR) shows promise as a tool for assessing and rehabilitating traumatic brain injury, which currently lacks effective pharmacological treatments.

Advancements in VR technology have made it more accessible and affordable, enabling its use in both clinical settings and daily life, potentially leading to long-term improvements in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Traumatic Brain Injury. Zanier, ER., Zoerle, T., Di Lernia, D., et al.[2020]

Virtual reality driving simulation rehabilitation training (VRDSRT) was well-received by military personnel recovering from traumatic brain injury (TBI), with no reported side effects like simulation sickness.

Participants in the VRDSRT group showed significant improvements in driving performance and reduced instances of road rage and risky driving behaviors, indicating its effectiveness as a rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. Cox, DJ., Davis, M., Singh, H., et al.[2021]

A study involving 20 patients with moderate to severe traumatic brain injury (TBI) found that non-immersive virtual reality-based cognitive training significantly improved executive functioning and reduced anxiety and depression symptoms compared to standard cognitive training.

The virtual reality training led to statistically significant improvements in various cognitive assessments, while the conventional training showed limited benefits, highlighting the potential of VR as a motivational and effective rehabilitation tool for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Virtual Reality Cognitive Rehabilitation Improve Executive Functioning and Coping Strategies in Traumatic Brain Injury? A Pilot Study. De Luca, R., Bonanno, M., Marra, A., et al.[2023]

A study involving 30 traumatic brain injury (TBI) patients showed that non-immersive virtual reality-based attention training significantly improved cognitive functions and mood compared to conventional training methods.

The virtual reality training led to notable improvements in global cognitive status, attention processes, and reduced depression symptoms, indicating its potential as an effective rehabilitation tool for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Non-Immersive Virtual Reality Improve Attention Processes in Severe Traumatic Brain Injury? Encouraging Data from a Pilot Study. De Luca, R., Bonanno, M., Rifici, C., et al.[2023]

A systematic review of 13 studies involving 132 patients with traumatic brain injury (TBI) found that virtual reality (VR) interventions can significantly improve various aspects of neurocognitive performance, such as learning, memory, and attention.

While some studies showed that improvements in cognitive performance could translate to real-life activities, more research is needed to validate these findings and ensure consistent real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Virtual Reality Interventions for Improvement of Neurocognitive Performance After Traumatic Brain Injury: A Systematic Review. Manivannan, S., Al-Amri, M., Postans, M., et al.[2022]

The study demonstrated that the at-home cognitive training tool NeuroTrackerX is feasible for use among cognitively healthy adults, with high recruitment and retention rates, and 90% adherence to the program over 10 sessions in 5 weeks.

Both the at-home group and the control group showed significant improvements in task performance, indicating that NeuroTrackerX could be an effective therapeutic option for cognitive training, particularly for traumatic brain injury survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Snowden, T., Ohlhauser, L., Morrison, J., et al.[2023]

A systematic review of 12 studies on virtual reality (VR) for rehabilitation in traumatic brain injury (TBI) patients found moderately positive evidence supporting its effectiveness for improving both motor skills and cognitive function.

The studies included varied in quality, indicating a need for more robust research to conclusively determine the efficacy of VR-enhanced rehabilitation techniques for TBI, suggesting that further exploration of immersive VR methods is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. Aulisio, MC., Han, DY., Glueck, AC.[2021]

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Virtual Reality Training for Traumatic Brain Injury (CMT Trial)

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