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

NCT05703360 | Not Yet Recruiting

• 1 other identifier: 22-5914
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Changes from baseline in visual attention and speed using Re:ViewD

  Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)

• Changes from baseline in visual fields

  Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)

• Simulator Sickness Questionnaire (SSQ)

  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

  Initial visit (day 0)

• Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period

  Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group)

Study Arms (2)

Waitlist Group

EXPERIMENTAL

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

VR Intervention First

EXPERIMENTAL

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

Interventions

Audiovisual Stimulation DEVICE

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.)

VR Intervention First; Waitlist Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of vertigo or dizziness.
• Visual neglect.
• Prior/current vision rehabilitation interventions.
• Photosensitive epilepsy.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

KITE Research Institute, UHN

Toronto, Ontario, M5G 2A2, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke; Vision Disorders; Vision, Low; Spatial Processing; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael Reber, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lora Appel, PhD

  York University

  PRINCIPAL INVESTIGATOR

• Jennifer Campos, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Tchao

CONTACT

647-408-9638; danielle.tchao@uhn.com

Lora Appel, PhD

CONTACT

lora.appel@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, pragmatic, cross-over, single-blind, multi-centre study

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 30, 2023
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CA (2)