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

No phase Interventional Stroke Visual Impairment Low Vision Virtual Reality

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audiovisual Stimulation.
Who it may be relevant to
Registry conditions: Stroke, Visual Impairment, Low Vision, Virtual Reality. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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)

Interventions

  • Device Audiovisual Stimulation
    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 o

Primary outcome measures

  • Changes from baseline in braking response (sec) [Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
  • Changes from baseline in collisions (total #) [Time frame: 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) [Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
  • Changes from baseline in speed variability (km/h) [Time frame: 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) [Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
Secondary outcome measures (5)
  • Changes from baseline in visual attention and speed using Re:ViewD [Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
  • Changes from baseline in visual fields [Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
  • Simulator Sickness Questionnaire (SSQ) [Time frame: 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 [Time frame: Initial visit (day 0)]
  • Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period [Time frame: Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Canada · 2 centers
  • KITE Research Institute, UHN — Toronto
  • Toronto Western Hospital — Toronto

Publications

  • Saredakis D, Szpak A, Birckhead B, Keage HAD, Rizzo A, Loetscher T. Factors Associated With Virtual Reality Sickness in Head-Mounted Displays: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2020 Mar 31;14:96. doi: 10.3389/fnhum.2020.00096. eCollection 2020. PMID 32300295
  • Richards E, Bennett PJ, Sekuler AB. Age related differences in learning with the useful field of view. Vision Res. 2006 Nov;46(25):4217-31. doi: 10.1016/j.visres.2006.08.011. Epub 2006 Oct 5. PMID 17027061

Identifiers

NCT: NCT05703360 · 22-5914

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗