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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new training method using virtual reality (VR) and augmented reality (AR) to help individuals with traumatic brain injury (TBI) improve walking and balance. The researchers aim to determine if adding cognitive tasks to physical training can make a noticeable difference. Participants will be divided into three groups to compare this personalized cognitive-sensorimotor VR/AR training with traditional training methods and standard care. Individuals who have had a TBI for at least six months and experience difficulties with walking or balance may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and quality of life.

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 prior data suggests that this virtual reality training is safe for individuals with traumatic brain injury?

Research has shown that personalized VR/AR training, involving both movement and cognitive tasks, is generally manageable for participants. This training uses virtual reality to enhance walking and balance. Reports of serious side effects have not emerged, making it a promising option for individuals with traumatic brain injuries.

Similarly, researchers have studied traditional dual-task training, which combines activities like walking and thinking, in people with neurological issues. Studies indicate it effectively improves mobility and cognitive skills without significant side effects. Both treatments aim to safely enhance walking and balance, which are crucial for gaining independence after a brain injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized cognitive-sensorimotor VR/AR training for traumatic brain injury because it introduces a new, immersive way to enhance recovery. Unlike standard treatments that focus on basic walking and balance exercises, this innovative approach integrates cognitive tasks into the training, using virtual and augmented reality to stimulate both the body and mind simultaneously. This dual-focus approach could potentially accelerate recovery by engaging multiple brain areas more effectively than traditional methods.

What evidence suggests that this trial's treatments could be effective for improving walking and balance after traumatic brain injury?

This trial will compare different training methods for individuals with traumatic brain injury (TBI). Participants in one group will receive personalized cognitive-sensorimotor VR/AR training. Research has shown that this approach can improve balance and walking by combining movement and cognitive tasks. Some studies suggest that this VR method can enhance motor skills and brain functions in TBI patients. Another group will undergo traditional dual-task training, which involves performing two tasks simultaneously, such as walking while solving a puzzle. Studies have supported that this method can improve both cognitive and motor abilities. Both methods aim to help TBI patients become more independent and reduce the risk of falls by enhancing mobility and cognitive skills. ^{1 2 3 4 5}

Who Is on the Research Team?

Kiran Karunakaran, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

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

Have approval from a physician to participate

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06473987

Personalized Cognitive Integrated Motor Training Using ... The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive ...

2. trialx.com trialx.com/clinical-trials/listings/324393/personalized-cognitive-integrated-motor-training-using-virtual-reality-to-improve-gait-and-balance/

Personalized Cognitive Integrated Motor Training Using ... The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06473987/personalized-cognitive-integrated-motor-training-using-virtual-reality-to-improve-gait-and-balance

Personalized Cognitive Integrated Motor Training Using ... The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized ...

4. withpower.com withpower.com/trial/phase-brain-injuries-7-2024-2aa6f

Virtual Reality Training for Traumatic Brain Injury (CMT Trial) 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 ...

5. kesslerfoundation.org kesslerfoundation.org/press-release/kessler-foundation-researchers-advance-traumatic-brain-injury-rehabilitation

Kiran Karunakaran, PhD, and Vikram Shenoy Handiru ... Karunakaran The study will use cognitive integrated sensorimotor training with virtual reality to improve functional ambulation. The study will ...