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ClinicalTrials.gov ID

NCT05703360

Lead Sponsor

University Health Network, TorontoOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Dec 19, 2024Actual

Start Date

Feb 1, 2025Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

Official Title

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

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:

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)

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

• Audiovisual Stimulation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Single

Lead Sponsor

University Health Network, TorontoOTHER

michael.reber@uhnresearch.ca