AV-Stimulation in VR for Vision Impairment

(Re:DriVR Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a virtual reality (VR) program, the IVR Stimulation Program, can enhance vision and driving skills for individuals who lost their license due to vision or cognitive issues. Participants will use the VR program every other day for six weeks to determine its impact on visual perception and attention, potentially making driving safer. Individuals who previously drove and now experience vision problems from a brain injury or stroke might be suitable candidates. The study will compare results between those who start VR training immediately and those who begin after a six-week delay. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for improving vision and driving skills.

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 prior data suggests that this IVR stimulation program is safe for improving visual perception?

Research has shown that immersive virtual reality (IVR) programs are generally safe for participants. One study focused on the safety of VR-based audiovisual stimulation and found that most participants tolerated it well, with only a few experiencing minor side effects. This suggests that the IVR program for vision impairment is likely safe for most individuals.

IVR technology has been used in healthcare for some time. While any technology can have side effects, studies indicate that many people tolerate IVR well. Participants in the trial might experience only minor discomfort or issues. As always, researchers will closely monitor safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VR audiovisual stimulation for vision impairment because it introduces a unique approach to treatment by combining visual and auditory cues in a virtual reality setting. Unlike traditional treatments, which may rely on corrective lenses, surgery, or medication, this method immerses patients in an interactive environment that could enhance sensory processing and potentially lead to improvements in vision. The innovative use of VR technology has the potential to offer a non-invasive, engaging, and adaptive therapy option that could be tailored to individual needs, setting it apart from conventional methods.

What evidence suggests that this IVR stimulation program is effective for improving visual perception?

Research shows that immersive virtual reality (IVR) can enhance perception and cognition. Earlier studies have found IVR technology promising for individuals with mild cognitive impairment (MCI), boosting their cognitive skills. Virtual reality has also simulated vision problems, aiding training and recovery. Early results suggest IVR can assist in visual rehabilitation. For instance, trials with children who had brain tumors showed improved vision. In this trial, participants will either begin with VR audiovisual stimulation or join a waitlist before receiving the intervention. Evidence suggests that IVR programs might also enhance driving skills and improve focus and field of vision. ^{1 2 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380326/

A randomized controlled pilot study protocol - PMC This study mainly investigates the feasibility and efficacy of immersive virtual reality-based cognitive stimulation therapy (IVR-CST) on MCI, ...

2. link.springer.com link.springer.com/article/10.1007/s10055-024-00987-0

Simulating vision impairment in virtual reality Our study evaluates the potential and limitations of using Virtual Reality technology to simulate the effects of tunnel vision within controlled virtual ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1568163725001175

Immersive virtual reality for older adults: Challenges and ... In this narrative review, we examine the challenges older adults face with IVR and explore strategies to optimize its design for this population.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10281573/

Virtual reality as a means to explore assistive technologies for ... Visual impairment represents a significant health and economic burden affecting 596 million globally. The incidence of visual impairment is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05065268

Study Details | NCT05065268 | Visual Rehabilitation in ... Feasibility and effectiveness of a home based audiovisual stimuaton in immersive virtual-reality to restore visual perception in children with brain tumour ...

6. ctv.veeva.com ctv.veeva.com/study/the-feasibility-safety-and-tolerability-of-vr-based-audiovisual-stimulation

The Feasibility, Safety and Tolerability of VR-based ... This is a single-blind, sham-controlled, clinical trial that aims to evaluate the safety, tolerability, and feasibility of delivering ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346243/

Effects of Immersive Virtual Reality on Physical Function ... Background/Objectives: This study aimed to evaluate the impact of an immersive virtual reality (IVR) program on balance, physical fitness, risk of falling, ...

8. uhnresearch.ca uhnresearch.ca/news/virtual-reality-restores-vision

Virtual Reality Restores Vision The program, called 3D-MOT IVR, uses audiovisual stimulation to help participants track objects across both the affected and unaffected portions ...