Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance
NCT ID: NCT05703360
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-02-01
2025-12-01
Brief Summary
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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
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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)
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Waitlist Group
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.
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 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
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.
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 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.)
Interventions
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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 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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Michael Reber, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Lora Appel, PhD
Role: PRINCIPAL_INVESTIGATOR
York University
Jennifer Campos, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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KITE Research Institute, UHN
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Jennifer Campos, PhD
Role: primary
Michael Reber, Ph.D
Role: primary
References
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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.
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.
Other Identifiers
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22-5914
Identifier Type: -
Identifier Source: org_study_id