Virtual Reality Training for Traumatic Brain Injury

(CMT Trial)

Overseen By Kiran K Karunakaran, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Uncontrolled seizures, Heart disease, Spinal cord injury, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

135 Participants Needed

Trial Summary

What is the purpose of this trial?

Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury. The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.

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

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study staff or your physician for guidance.

What data supports the idea that Virtual Reality Training for Traumatic Brain Injury is an effective treatment?

The available research shows that Virtual Reality (VR) Training can be an effective treatment for Traumatic Brain Injury (TBI). One study found that using VR with an intelligent glove system improved hand function in TBI patients by providing visual and audio feedback, which helped them perform tasks better. Another study highlighted that VR can motivate people to participate in motor rehabilitation, which is crucial for recovery. Although the evidence is mixed, these studies suggest that VR can help improve motor skills and cognitive functions in TBI patients by making therapy more engaging and personalized. ^{1 2 3 4 5}

What safety data exists for virtual reality training in traumatic brain injury rehabilitation?

The safety of virtual reality (VR) training for brain rehabilitation has been evaluated in several studies. A pilot study on immersive VR training for brain injury patients reported no serious adverse events, though some patients experienced dizziness. Satisfaction with the training was higher among those who adhered to the program. Another study on non-immersive VR for attention training in traumatic brain injury (TBI) patients showed promising results, but specific safety data was not detailed. Overall, VR appears to be a safe and promising tool for rehabilitation in TBI patients, with potential benefits in motor and cognitive recovery. ^{3 6 7 8 9}

Is the treatment using virtual reality for traumatic brain injury promising?

Yes, virtual reality treatment for traumatic brain injury is promising. It can improve attention, cognitive functions, and mood. It also helps with executive functions like planning and problem-solving, and enhances coping strategies. Overall, it offers a motivational and effective approach for rehabilitation. ^{1 8 9 10 11}

Research Team

Kiran Karunakaran, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for adults aged 18-65 living with traumatic brain injury (TBI) for at least 6 months. Participants must be able to follow instructions, speak English, and have a walking speed below 0.8 m/s. They should not have leg injuries or medical issues affecting walking, severe memory loss, or significant vision problems.

Inclusion Criteria

I have been living with a traumatic brain injury for at least 6 months.

Have approval from a physician to participate

My walking speed is slower than 0.8 meters per second.

Exclusion Criteria

I have a health condition that makes it hard for me to exercise.

Have skin issues that would prevent from wearing a safety harness

Have been diagnosed with cognitive (thinking) problems prior to TBI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo personalized cognitive integrated sensorimotor VR/AR training, traditional dual-task training, or standard of care for gait and balance improvement

10 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized cognitive-sensorimotor VR/AR training
• Standard of Care
• Traditional dual-task training

Trial Overview The study tests three approaches to improve gait and balance in TBI patients: personalized VR/AR training combining movement and cognitive tasks; traditional dual-task training; and standard care. It aims to understand the impact on mobility, cognition, and related brain activity.

Participant Groups

Group I: Personalized cognitive-sensorimotor VR/AR training Experimental Treatment 1 Intervention

Thinking task integrated walking and balance training program

Group II: Traditional dual-task training Active Control 1 Intervention

Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training.

Group III: Standard of Care Active Control 1 Intervention

Standard walking and balance training

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Findings from Research

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]

Interactive multimodal rehabilitation using a Mixed Reality system may improve cognitive therapy outcomes for stroke patients by promoting neural plasticity during recovery.

Initial results from a trial with 14 participants indicate that this system could also benefit individuals with traumatic brain injury (TBI), showing promise for broader applications in cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Therapy Using Mixed Reality for Those Impaired by a Cerebrovascular Accident (CVA). Salva, AM., Wiederhold, BK., Alban, AJ., et al.[2018]

In a study involving 7 participants with traumatic brain injury (TBI) and 13 neurotypical individuals, the use of multimodal feedback in virtual reality significantly improved motor performance in the TBI group, indicating its potential for enhancing rehabilitation outcomes.

Both TBI and neurotypical groups showed increased EEG alpha power after training, but only the TBI group exhibited notable improvements in task performance and EMG activity, suggesting that augmented sensory feedback is particularly beneficial for individuals with neurological dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented feedback modes during functional grasp training with an intelligent glove and virtual reality for persons with traumatic brain injury. Liu, M., Wilder, S., Sanford, S., et al.[2023]

Task-oriented training (TOT) approaches, which involve challenging and meaningful activities, have shown successful outcomes in neurorehabilitation for stroke recovery, supported by large-scale trials.

Recent advancements in virtual reality and robotics enhance neurorehabilitation by providing multimodal sensory interfaces that can monitor and improve patient interactions, promoting functional recovery in a patient-centered manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and robotics for stroke rehabilitation: where do we go from here? Wade, E., Winstein, CJ.[2016]

The tabletop virtual-reality rehabilitation system, Elements, showed promise in improving movement accuracy, efficiency, and bimanual dexterity in three patients with traumatic brain injury (TBI) after 12 one-hour training sessions.

While participants experienced mixed results in speed and other movement skills, the overall improvements suggest that this VR-based approach could be effective for motor learning in TBI patients, warranting larger scale trials for further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper limb virtual rehabilitation for traumatic brain injury: initial evaluation of the elements system. Mumford, N., Duckworth, J., Thomas, PR., et al.[2019]

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]

The Dynavision visuomotor reaction task implemented in virtual reality (VR) showed high test-retest reliability among 64 healthy physically-active students, indicating it is a dependable tool for assessing visuomotor integration.

The use of VR technology allowed for the capture of head movements, providing valuable insights into individual visual-perceptual strategies and enabling the identification of distinct visuomotor phenotypes, which could enhance rehabilitation and training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of the Dynavision task in virtual reality to explore visuomotor phenotypes. Pratviel, Y., Deschodt-Arsac, V., Larrue, F., et al.[2021]

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]

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 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 100 patients with traumatic brain injury (TBI) showed that virtual reality training (VRT) with BTs-Nirvana significantly improved cognitive flexibility and selective attention compared to traditional cognitive rehabilitation.

Both VRT and traditional methods improved overall cognitive functioning and mood, but the virtual reality approach demonstrated superior benefits in specific cognitive skills, suggesting it could be a more effective rehabilitation tool for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Cognitive Function after Traumatic Brain Injury: A Clinical Trial on the Potential Use of the Semi-Immersive Virtual Reality. De Luca, R., Maggio, MG., Maresca, G., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive Therapy Using Mixed Reality for Those Impaired by a Cerebrovascular Accident (CVA). [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Augmented feedback modes during functional grasp training with an intelligent glove and virtual reality for persons with traumatic brain injury. [2023]

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

Virtual reality and robotics for stroke rehabilitation: where do we go from here? [2016]

5. England pubmed.ncbi.nlm.nih.gov

Upper limb virtual rehabilitation for traumatic brain injury: initial evaluation of the elements system. [2019]

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

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Reliability of the Dynavision task in virtual reality to explore visuomotor phenotypes. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Does Non-Immersive Virtual Reality Improve Attention Processes in Severe Traumatic Brain Injury? Encouraging Data from a Pilot Study. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality for Traumatic Brain Injury. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Can Virtual Reality Cognitive Rehabilitation Improve Executive Functioning and Coping Strategies in Traumatic Brain Injury? A Pilot Study. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Improving Cognitive Function after Traumatic Brain Injury: A Clinical Trial on the Potential Use of the Semi-Immersive Virtual Reality. [2020]