Mixed Reality Rehabilitation for Traumatic Brain Injury

(Praxis Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BlueHalo

Must not be taking: Mind-altering substances, Alcohol

Disqualifiers: Impaired mental capacity, Significant pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new rehabilitation method using mixed reality tools to aid military members in recovering from mild traumatic brain injury (mTBI). Researchers aim to determine if this approach can improve balance, coordination, and overall readiness for those experiencing dizziness or imbalance after an mTBI. Participants will either use the mixed reality system called Praxis, a portable mixed reality-based platform, or engage in regular supervised exercise to compare results. The trial seeks military service members who have experienced mTBI and continue to face balance or dizziness issues. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance recovery methods for mTBI.

Will I have to stop taking my current medications?

The trial requires participants to avoid alcohol and medications that might affect balance or blood flow to the brain for 24 hours before testing.

What prior data suggests that this mixed reality rehabilitation method is safe for military service members with mTBI?

Research shows that participants generally tolerate the portable mixed reality system used in the Praxis study well. In past studies, similar systems have been used for rehabilitation involving multiple senses without major safety issues. This system assists military members with mild traumatic brain injuries (mTBI) by offering exercises like eye movement and balance training.

Although this trial doesn't list specific side effects, mixed reality platforms in rehabilitation have been positively received, with most participants handling the exercises well. This suggests that the treatment is likely safe, especially since it focuses on gentle activities aimed at recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mixed Reality Rehabilitation for Traumatic Brain Injury because it offers a fresh approach to addressing post-acute mild traumatic brain injury (mTBI) symptoms like dizziness and imbalance. Unlike standard treatments that often involve medication or traditional physical therapy, this treatment uses a portable mixed reality-based platform, which immerses patients in a virtual environment to enhance their rehabilitation experience. This innovative method aims to directly engage and stimulate the brain's recovery process through interactive exercises, potentially accelerating progress and improving outcomes for patients with mTBI.

What evidence suggests that this mixed reality rehabilitation platform is effective for traumatic brain injury?

Research has shown that mixed reality platforms can aid recovery for people with traumatic brain injuries (TBI). Studies have found that digital exercises improve thinking skills in TBI patients. Mixed reality technology also helps with balance and movement, often affected by mild TBI. Evidence suggests these tools enhance recovery and performance. In this trial, participants in the Praxis arm will use a mixed reality approach, which may benefit military service members with mild TBI symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Pedram Hovareshti, PhD

Principal Investigator

BlueHalo

Are You a Good Fit for This Trial?

This trial is for military service members who have suffered a mild Traumatic Brain Injury (mTBI) and are part of the Center for the Intrepid's Special Operations Performance and Recovery Program. Participants should be in the post-acute phase of mTBI to qualify.

Inclusion Criteria

Participating in the SPaR Program

Have a self-reported or clinician-confirmed mTBI

Have continued complaints of dizziness/imbalance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 weeks of multisensory vestibular rehabilitation including gaze stabilization, dual-task balance training, spatial navigation, and agility training

4 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Portable Mixed Reality-based Platform

Trial Overview The study tests Praxis, a mixed reality platform with wearable sensors, against supervised cardiovascular exercise to see if it improves multisensory rehabilitation outcomes after mTBI. The program includes gaze stabilization, balance training, spatial navigation, and agility over four weeks.

How Is the Trial Designed?

Group I: Praxis Experimental Treatment 1 Intervention

Fifteen SMs with post-acute mTBI and residual dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of Praxis intervention (45 minutes, 5 days per week)

Group II: Control Active Control 1 Intervention

Fifteen SMs without dizziness/imbalance complaints from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will receive 4 weeks of supervised cardiovascular activity (45 minutes, 5 days per week)

Who Is Running the Clinical Trial?

BlueHalo

Lead Sponsor

Trials

2

Recruited

110+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06314464

Portable Mixed Reality-based Platform for Assessment of ... The primary endpoints for this study are feasibility/acceptability of the 4-week multisensory rehabilitation for SMs with post-acute mTBI as determined by ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11119161/

Virtual Reality-Based Interventions to Improve Balance in ... The aim of this study was to determine if stress reactivity and postural control are susceptible to long-term consequences of mild traumatic ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505623002538

Challenges and promises of mixed-reality interventions in ... This scoping review aims to explore MR-systems in ABI rehabilitation, while assessing the evidence base and technology readiness levels of these systems.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... This meta-analysis supports the efficacy of digital cognitive intervention in improving cognitive function in TBI patients. We recommend ...

5. withpower.com withpower.com/trial/phase-vestibular-diseases-1-2024-3b856

Mixed Reality Rehabilitation for Traumatic Brain Injury · Info ... What data supports the effectiveness of the treatment Portable Mixed Reality-based Platform for Traumatic Brain Injury? Research shows that mixed reality ...

6. ctv.veeva.com ctv.veeva.com/study/portable-mixed-reality-based-platform-for-assessment-of-progress-in-multisensory-rehabilitation-stra

Portable Mixed Reality-based Platform for Assessment of ... The second purpose of this study is to determine the average values and variations of the behavioral outcome measures before and after ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1558795/full

A virtual reality system for delivery of military-specific ... A virtual reality system for delivery of military-specific vestibular rehabilitation after mild traumatic brain injury: the Praxis study ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12133483/

A virtual reality system for delivery of military-specific ... A virtual reality system for delivery of military-specific vestibular rehabilitation after mild traumatic brain injury: the Praxis study protocol