Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance

Study Overview
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Brief Summary
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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: Can the 6-week IVR stimulation program help improve driving performance? 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.

Detailed Description
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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: Period 1 (Waitlist Group vs Intervention-First Group) Waitlist Group (Period 1 vs Period 2) Intervention-First Group (Period 1 vs Period 2)

Official Title
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Effectiveness of Audiovisual Stimulation in Immersive Virtual Reality to Improve Visual Perception and Driving Performance: a Pilot Study

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

Intervention / Treatment
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* Device: Audiovisual Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Interventional, pragmatic, cross-over, single-blind, multi-centre study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Waitlist Group<br>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. | Device: Audiovisual Stimulation<br>* The device application involves the 3D multiple-object-tracking (3D-MOT) paradigm composed of 8 high-contrast spheres which are adapted to the visual ability of participant (luminosity and size). The initial speed of the spheres is adjustable and determined during the inclusion visit. One or more of the spheres is temporarily highlighted (target). Then all 8 spheres move for 20 seconds following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. After 20 seconds, the movement stops and the participant is asked to select, using the hand controller, the initially highlighted target(s) among the 8 spheres. If the selection is correct the speed of the spheres in the next trial is increased. If the selection is incorrect the speed of the spheres in the next trial is decreased. Based on performance, stimulations will be adjusted to change difficulty level (e.g. changing backgrounds, number of cued balls, etc.)<br>|
| Experimental: VR Intervention First<br>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. | Device: Audiovisual Stimulation<br>* The device application involves the 3D multiple-object-tracking (3D-MOT) paradigm composed of 8 high-contrast spheres which are adapted to the visual ability of participant (luminosity and size). The initial speed of the spheres is adjustable and determined during the inclusion visit. One or more of the spheres is temporarily highlighted (target). Then all 8 spheres move for 20 seconds following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. After 20 seconds, the movement stops and the participant is asked to select, using the hand controller, the initially highlighted target(s) among the 8 spheres. If the selection is correct the speed of the spheres in the next trial is increased. If the selection is incorrect the speed of the spheres in the next trial is decreased. Based on performance, stimulations will be adjusted to change difficulty level (e.g. changing backgrounds, number of cued balls, etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in braking response (sec) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Changes from baseline in collisions (total #) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Changes from baseline in lane keeping (meters of deviations/departures) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Changes from baseline in speed variability (km/h) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Changes from baseline in road rule violations (# and type) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in visual attention and speed using Re:ViewD | This vision test will be completed within the VR headset and will measure visual processing speed, sustained visual attention, and divided visual attention. This is a VR version of the Useful Field of View (UFoV) test which has been extensively used to measure visual attention in healthy individuals and older adults with low vision. Outcome measures are time of display (ms) for 75% of correct responses. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Changes from baseline in visual fields | Visual fields are evaluated with the automated Humphrey Field Analysis III using Esterman binocular field test procedure at Toronto Western Hospital. Outcome measures are number of points seen among 120 points. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Simulator Sickness Questionnaire (SSQ) | The SSQ will be administered after each driving session to capture any feelings related to simulator sickness. The SSQ is a validated 16-item questionnaire that assesses various symptom categories of simulator sickness. Responses are made on a 4-point scale ranging from not at all (total score = 0) to severe (total score =235.62). A total score (TS) ≥ 150 corresponds to mild to severe symptoms. Three subscales within the SSQ specifically targeting feelings of nausea (SSQ-N), oculomotor disturbances (SSQ-O), and disorientation (SSQ-D) as well as a total score (SSQ-TS) can be calculated based on pre-defined factor weightings. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | 
| Virtual-Reality Induced Symptoms and Effects (VRISE) - initial screening | This questionnaire is made up of five (5) questions related to possible cybersickness symptoms and will be completed within the VR headset by using the hand controller. Participants will complete the VRISE immediately after being trained on how to use the VR intervention at the initial visit. The VRISE score ranges from 5 (very intense level of symptoms and effects) to 35 (very low level of symptom and effects). | Initial visit (day 0) | 
| Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period | This questionnaire is made up of five (5) questions related to possible cybersickness symptoms and will be completed within the VR headset by using the hand controller. Participants will complete the VRISE immediately after being trained on how to use the VR intervention at the initial visit. The VRISE score ranges from 5 (very intense level of symptoms and effects) to 35 (very low level of symptom and effects). | Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group) |