Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance (Re:DriVR)

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Low Vision; Cognitive Impairment; Visual Spatial Processing; Stroke; Visual Processing Speed; Driving Impaired; Visual Field Defect; Visual Impairment; Virtual Reality

Treatments: Device: Audiovisual Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05703360

22-5914

Details and patient eligibility

About

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.

Full description

This clinical trial will be an interventional, cross-over, single blind, randomized, supportive care, single-center study lasting 12 weeks with a target recruitment of 30 participants.

SCREENING AND BASELINE TESTS

Potential participants will be identified from patients receiving routine care at Toronto Western Hospital by their ophthalmologist. After obtaining informed consent and screened for inclusion, the research coordinator will set up appointments for each participant to complete baseline tests related to driving performance, visual attention, and visual fields. Participants will also practice the IVR program and be assessed for IVR sensitivity, or cybersickness, using the Virtual-Reality Induced Symptoms and Effects (VRISE) questionnaire.

Participants will be randomized into a Waitlist group or Intervention-First group. The Intervention-First group will be given a head-mounted display (HMD) to take home for training.

INTERVENTION (Week 1 - 12)

Period 1 (Week 1-6):

• Waitlist Group has no intervention
• Intervention-First group trains at home every 2 days using HMD

All participants are booked for their second appointments to repeat baseline tests once Period 1 is complete. Intervention-first group will return their HMD to the researchers and Waitlist group will be given their HMD to take home.

Period 2 (Week 7-12)

• Waitlist Group trains at home every 2 days using HMD
• Intervention-First group has no intervention

All participants are booked for their third appointments to repeat baseline tests once Period 2 is complete. Waitlist group will return their HMD to researchers.

POST-INTERVENTION

Analysis of outcome measures:

1. Period 1 (Waitlist Group vs Intervention-First Group)
2. Waitlist Group (Period 1 vs Period 2)
3. Intervention-First Group (Period 1 vs Period 2)

Enrollment: 30 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female > 25 years old.
• Visual field defects due to TBI or stroke
• BCVA ≥ 20/50.
• Previously held a valid driving license and were active drivers.
• Ability to follow the visual and auditory stimuli and training instructions.
• Online auditory test positive (-5dBHL to 60dBHL range) at 125 Hz (for research purposes only)
• Home Wi-Fi access.

Exclusion criteria

• Both eyes with media opacity that impairs visual field testing.
• Inability to perform during testing and training.
• Cognitive/motor condition incompatible with driving simulator and/or VR.
• Recreational or medicinal consumption of psychoactive drugs.
• 3 consecutive VRISE scores < 25 at inclusion.
• History of vertigo or dizziness.
• Visual neglect.
• Prior/current vision rehabilitation interventions.
• Photosensitive epilepsy.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Waitlist Group

Experimental group

Description:

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.

Treatment:

Device: Audiovisual Stimulation

VR Intervention First

Experimental group

Description:

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.

Treatment:

Device: Audiovisual Stimulation