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

Trial Summary

What is the purpose of this trial?

Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.

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 data supports the effectiveness of the treatment Virtual Reality Neurocognitive 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. VR interventions have been found effective in enhancing neurocognitive performance, suggesting that VR exercises could be beneficial for TBI rehabilitation. ^{1 2 3 4 5}

Is virtual reality exercise safe for people with traumatic brain injury?

Research on virtual reality exercises for traumatic brain injury suggests that it is generally safe for humans, as studies have focused on its feasibility and impact on cognitive rehabilitation without reporting significant safety concerns. ^{1 2 3 4 6}

How is Virtual Reality Neurocognitive Therapy different from other treatments for traumatic brain injury?

Virtual Reality Neurocognitive Therapy is unique because it uses virtual reality (VR) to create interactive environments that help improve cognitive function after a traumatic brain injury. Unlike traditional therapies, VR allows for real-time simulation and engagement, making it accessible both at the bedside and in daily life, potentially offering long-term benefits without the need for medication. ^{1 2 5 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

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

Improving cognitive function after brain injury: the use of exercise and virtual reality. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Examining the effect of virtual reality therapy on cognition post-stroke: a systematic review and meta-analysis. [2022]

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

The Effectiveness of Virtual Reality Interventions for Improvement of Neurocognitive Performance After Traumatic Brain Injury: A Systematic Review. [2022]

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

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality for Traumatic Brain Injury. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

NeuroVR 2--a free virtual reality platform for the assessment and treatment in behavioral health care. [2011]

7. Italy pubmed.ncbi.nlm.nih.gov

[Virtual reality: a simple joke or therapeutic instrument?]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. [2021]