AV-Stimulation in VR for Vision Impairment

(Re:DriVR Trial)

Recruiting at 1 trial location

Overseen By Lora Appel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Psychoactive drugs

Disqualifiers: Media opacity, Cognitive/motor issues, Vertigo, others

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

Compensation: Varies

Number of Visits: 7

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness of an immersive virtual-reality (IVR) based stimulation program, in improving visual perception for people who have lost their driver's license due to perceptual or cognitive impairments. The main questions it aims to answer are: 1. Can the 6-week IVR stimulation program help improve driving performance? 2. Will participants experience improvement in visual detection and perception after training? Study Design Summary: * Participants will be randomized into a waitlist group or intervention-first group * The VR-based intervention will consist of training every 2 days for six weeks * Waitlist group will wait 6 weeks before starting intervention at study midpoint (week 7) * Intervention-first group will begin with intervention (week 1-6) and then stop intervention at study midpoint * Participants will complete tests related to driving performance, visual attention, and visual fields at the start of study, midpoint, and end of study Researchers will analyze data for changes from baseline in outcome measures.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you use recreational or medicinal psychoactive drugs, you may not be eligible to participate.

What data supports the effectiveness of the IVR Stimulation Program treatment for vision impairment?

Research shows that virtual reality (VR) can help improve visual perception and quality of life for people with vision impairments. For example, a study found that VR applications with high brightness improved object and color recognition in a person with macular degeneration. Another study demonstrated that a VR-based audiovisual program enhanced visual function in a patient with hemianopia, suggesting potential benefits for other vision impairments. ^{1 2 3 4 5}

Is AV-Stimulation in VR generally safe for humans?

Research on virtual reality (VR) for vision impairment, including audiovisual stimulation programs, suggests it can be safely used at home for rehabilitation without interrupting care. Studies have shown improvements in visual function and quality of life, with no reported safety concerns. ^{1 2 3 6 7}

How does the IVR Stimulation Program treatment differ from other treatments for vision impairment?

The IVR Stimulation Program is unique because it uses virtual reality (VR) technology to provide audiovisual stimulation, allowing patients to undergo rehabilitation at home without frequent clinic visits. This approach is novel as it combines VR with remote control and real-time data recording, making it more accessible and convenient compared to traditional treatments that require large equipment and clinical settings. ^{3 4 8 9 10}

Research Team

Michael Reber, MD

Principal Investigator

University Health Network, Toronto

Lora Appel, PhD

Principal Investigator

York University

Jennifer Campos, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 25 who've lost their driver's license due to vision problems from a stroke or brain injury. They must have had a valid license, be able to follow the program, pass an online hearing test, and have home Wi-Fi. People with certain cognitive conditions, drug use, vertigo, prior vision therapy, severe visual neglect or epilepsy can't join.

Inclusion Criteria

I can see, hear, and follow instructions well.

I used to have a valid driving license and drove regularly.

I have vision problems because of a brain injury or stroke.

Exclusion Criteria

I have undergone vision rehabilitation.

You have a condition that makes it unsafe for you to use a driving simulator or virtual reality.

I cannot perform tasks during tests and training.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Testing

Participants complete baseline tests related to driving performance, visual attention, and visual fields. They also practice the IVR program and are assessed for IVR sensitivity using the VRISE questionnaire.

1 week

1 visit (in-person)

Intervention Period 1

Intervention-First group trains at home every 2 days using HMD, while the Waitlist group has no intervention.

6 weeks

2 visits (in-person) for testing

Intervention Period 2

Waitlist group trains at home every 2 days using HMD, while the Intervention-First group has no intervention.

6 weeks

2 visits (in-person) for testing

Follow-up

Participants are monitored for changes from baseline in outcome measures such as driving performance, visual attention, and visual fields.

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• IVR Stimulation Program

Trial Overview The study tests if a 6-week immersive VR program can improve visual perception and driving skills in people with vision loss. Participants are split into two groups: one starts training immediately and the other waits six weeks before starting. Their driving performance and visual abilities are tested before, halfway through, and after the program.

Participant Groups

Group I: Waitlist Group Experimental Treatment 1 Intervention

Those randomly assigned to the waitlist group will complete initial inclusion tests and baseline tests at Visit 1. They will receive no intervention during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. Next they will perform the VR audiovisual stimulation during Period 2 (week 7-12) and then repeat baseline tests post-intervention at Visit 3.

Group II: VR Intervention First Experimental Treatment 1 Intervention

Those randomly assigned to the intervention-first group will complete initial inclusion tests and baseline tests at Visit 1. They will perform the VR audiovisual stimulation during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. They will receive no intervention during Period 2 (week 7-12) and then repeat baseline tests at Visit 3.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

A virtual reality platform was developed to test and train users on an electronic travel aid, which includes a wearable haptic feedback device, showing significant improvements in navigation for individuals simulating three types of visual impairments.

Participants using the electronic travel aid completed tasks faster and experienced fewer collisions, particularly those simulating diabetic retinopathy and glaucoma, suggesting that this technology could enhance mobility rehabilitation for people with visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a means to explore assistive technologies for the visually impaired. Ricci, FS., Boldini, A., Ma, X., et al.[2023]

A 4-week virtual-reality audiovisual rehabilitation program significantly improved visual perception, contrast sensitivity, and fixation stability in a 15-year-old patient with right homonymous hemianopia, enhancing his quality of life.

This study demonstrates that remote-controlled virtual-reality therapy can effectively provide low-vision rehabilitation at home, challenging the notion that vision loss after injury is permanent and unchangeable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. Daibert-Nido, M., Pyatova, Y., Cheung, KG., et al.[2021]

A study involving 50 individuals with visual impairment showed that 60 hours of training in special software and mobile apps significantly improved quality of life across multiple dimensions, including mobility and reading skills.

This training not only enhanced participants' independence and ability to manage daily activities but also reduced their reliance on assistance, marking a promising rehabilitation approach for individuals with visual impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of special software training on quality of life among people with visual impairment. Bhaskaran, S., Ravikumar, P., Flora, J., et al.[2023]

Training individuals with low vision using virtual reality can effectively teach them safe street crossing skills, as demonstrated by a study involving 12 participants who improved their timing for crossing streets after training.

Both virtual and real street training resulted in significant safety improvements, with 90% of participants' 'GO' calls occurring in the safer early half of the pedestrian phase after training, indicating that virtual reality can be a viable alternative to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individuals with severely impaired vision can learn useful orientation and mobility skills in virtual streets and can use them to improve real street safety. Bowman, EL., Liu, L.[2022]

The Interactive Binocular Treatment (I-BiT) system is a novel virtual-reality approach designed to treat amblyopia by stimulating both eyes simultaneously, addressing issues of compliance and effectiveness seen with traditional patching methods.

This interactive VR system is adaptable to the patient's age and abilities, making the treatment more engaging and enjoyable, with ongoing research to evaluate its efficacy in improving amblyopia outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified virtual reality technology for treatment of amblyopia. Eastgate, RM., Griffiths, GD., Waddingham, PE., et al.[2019]

The newly developed audiovisual telerehabilitation (AVT) system has shown promising results in improving visual detection abilities in three adult patients with visual field defects, indicating its potential efficacy.

This telerehabilitation approach allows therapists to remotely monitor and control training sessions, which could lead to significant cost savings and reduced hospital stays for patients with visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a New Telerehabilitation System for Audiovisual Stimulation Training in Hemianopia. Tinelli, F., Cioni, G., Purpura, G.[2020]

References

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

The Accessibility of Commercial Off-The-Shelf Virtual Reality for Low Vision Users: A Macular Degeneration Case Study. [2020]

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

Virtual reality as a means to explore assistive technologies for the visually impaired. [2023]

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

An Audiovisual 3D-Immersive Stimulation Program in Hemianopia Using a Connected Device. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Impact of special software training on quality of life among people with visual impairment. [2023]

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

Comparison of Visual Parameters Between Normal Individuals and People with Low Vision in a Virtual Environment. [2020]

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

Individuals with severely impaired vision can learn useful orientation and mobility skills in virtual streets and can use them to improve real street safety. [2022]

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

Modified virtual reality technology for treatment of amblyopia. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Blind persons navigate in virtual reality (VR); hearing and feeling communicates "reality". [2004]

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

Development and Implementation of a New Telerehabilitation System for Audiovisual Stimulation Training in Hemianopia. [2020]

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

EarVR: Using Ear Haptics in Virtual Reality for Deaf and Hard-of-Hearing People. [2021]