Virtual Reality Exercises for Traumatic Brain Injury

(BRIGHT Trial)

Overseen By Mira Ghneim

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Cognitive impairment, Seizure disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) exercises can improve cognitive functions like attention and memory in older adults who have experienced a mild traumatic brain injury (mTBI). The researchers aim to determine if VR can offer a new way to enhance recovery from these injuries by engaging participants in activities that mimic real-life scenarios. Participants will be divided into two groups: one using VR exercises and the other not using VR. The study seeks participants who are 65 years or older, live in their own communities, have had a mild TBI, and reside within 30 miles of the trauma center. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancing care for mTBI patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this virtual reality application is safe for cognitive rehabilitation in older adults with mild traumatic brain injury?

Research has shown that virtual reality (VR) exercises are generally safe for people with traumatic brain injuries (TBI). Studies have examined the practicality and safety of using VR for rehabilitation in these cases. In past research, TBI patients responded well to VR treatments, which improved their cognitive skills, such as attention and memory. These findings suggest that VR is a promising and safe tool for mental recovery after a TBI. Although rare, any negative effects were usually mild, such as temporary dizziness or discomfort. Overall, participants found VR exercises manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) neurocognitive exercises for treating traumatic brain injury (TBI) because this approach offers a unique, immersive way to engage and stimulate the brain. Unlike traditional therapies that rely on physical exercises or cognitive tasks, VR exercises create an interactive environment that can be tailored to each individual's needs, potentially enhancing motivation and participation. Additionally, VR technology allows for real-time feedback and progress tracking, which could lead to more personalized and effective rehabilitation strategies. By providing a novel method to actively involve patients in their recovery, VR exercises hold the promise of improving outcomes for those with TBI.

What evidence suggests that virtual reality exercises are effective for traumatic brain injury?

Research has shown that virtual reality (VR) therapy can improve thinking skills in people with traumatic brain injury (TBI). In this trial, participants in the VR group will receive Virtual Reality Neurocognitive Exercises. Studies have found these exercises enhance abilities like attention, memory, and task-switching. TBI patients often respond well to VR treatments, especially when tailored to specific cognitive or motor skills needing improvement. VR proves effective by providing engaging and realistic settings adjustable for various cognitive challenges. It offers a promising tool for recovering thinking skills, bringing hope to those with mild TBI. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who live within 30 miles of the trauma center, have an active phone number, and can provide informed consent. They must be diagnosed with mild traumatic brain injury (mTBI), speak English, and not reside in a care facility.

Inclusion Criteria

You are living in the community.

You are located within 30 miles of the trauma center.

I have an active phone number.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in virtual reality mediated cognitive exercises to improve executive function

6 weeks

Follow-up

Participants are monitored for changes in cognitive function and safety after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Neurocognitive Exercises

Trial Overview The BRIGHT Study tests if virtual reality neurocognitive exercises using an Oculus headset can improve attention, memory, and visual-spatial skills in older adults with mTBI compared to a control group without this intervention.

How Is the Trial Designed?

Group I: VR-Group Experimental Treatment 1 Intervention

Group II: No-VR Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Virtual reality is being successfully used in rehabilitative neurology to assess and treat central nervous system (CNS) injuries.

The authors developed a prototype simulation that recreates virtual environments to evaluate essential daily living skills in individuals with CNS damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Virtual reality: a simple joke or therapeutic instrument?]. Santacroce, L., Minervini, MM., Gagliardi, S., et al.[2006]

A systematic review of eight studies with 196 participants found that exercise-based virtual reality (VR) therapy did not show significant improvements in cognitive function compared to control interventions for individuals post-stroke.

Despite the lack of cognitive benefits, VR therapy was noted for its potential to enhance patient satisfaction and provide adaptable rehabilitation experiences, suggesting it may still be valuable in stroke recovery settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the effect of virtual reality therapy on cognition post-stroke: a systematic review and meta-analysis. Wiley, E., Khattab, S., Tang, A.[2022]

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]

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]

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]

NeuroVR 2 is an advanced virtual reality platform designed for clinical and experimental use, allowing therapists to customize environments to enhance patient familiarity and comfort, which is crucial for effective therapy.

The platform includes features like collision detection, realistic motion, and advanced lighting, which improve the realism of virtual environments, potentially leading to better therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NeuroVR 2--a free virtual reality platform for the assessment and treatment in behavioral health care. Riva, G., Gaggioli, A., Grassi, A., et al.[2011]

A study involving 31 individuals with chronic traumatic brain injury (TBI) found that treadmill training combined with virtual reality is safe and feasible, with no serious adverse events reported during the 4-week intervention.

All participants showed improvements in balance and mobility measures after the training, indicating that both virtual reality and treadmill training could be effective methods for enhancing recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. Tefertiller, C., Ketchum, JM., Bartelt, P., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10743630/

Use of Virtual Reality in Patients with Acquired Brain Injury Results: We found that TBI patients responded positively to VR treatment depending on the damaged or impaired cognitive and motor functions they ...

2. currents.neurocriticalcare.org currents.neurocriticalcare.org/Leading-Insights/Article/virtual-reality-for-neurorehabilitation-mechanisms-modalities-and-clinical-applications

Virtual Reality for Neurorehabilitation: Mechanisms, Modalities ... As such, VR has been shown to improve cognitive flexibility, shifting skills, and selective attention in survivors of acute brain injury, while ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7918687/

Virtual Reality for Neurorehabilitation and Cognitive ... VR also significantly increases cognitive flexibility, shifting skills, and selective attention, leading to better behavioral outcomes in brain-injured patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325008019

Virtual Reality in Training of Sustained Attention ... Virtual reality (VR) has emerged as a promising tool for cognitive rehabilitation after TBI, due to its immersive capabilities., VR is defined ...

5. withpower.com withpower.com/trial/phase-brain-injuries-9-2023-82ee5

Virtual Reality Exercises for Traumatic Brain Injury Research shows that virtual reality (VR) therapy can help improve cognitive function in people with traumatic brain injury (TBI) and stroke.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265412/

Virtual reality and cognitive function rehabilitation after ... VR is a potent post-TBI rehabilitative tool that can improve CF in this population and facilitate the return-to-work process.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02411227

Study Details | NCT02411227 | Neurocognitive Driving ... NeuroDRIVE uses a virtual reality driving simulator. Researchers think it can help test and improve how people think and drive after TBI.

8. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2025.2482838?af=R

Full article: A virtual rehabilitation tool for cognitive ... The VR tool provided a practical setting where clients with TBI can develop insight and awareness into the impact of their brain injury on their function, learn ...