An interventional study of Audiovisual Stimulation in Stroke, Visual Impairment and Low Vision, sponsored by University Health Network, Toronto. Not yet recruiting at 2 sites in Canada. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care
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:
Study Design Summary:
Researchers will analyze data for changes from baseline in outcome measures.
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):
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)
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:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.)
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.
Time frame: 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.
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)
Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
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)
Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
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)
Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Time frame: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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).
Time frame: Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group)
Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 10 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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