NCT05703360Not yet recruiting
Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance
Effectiveness of Audiovisual Stimulation in Immersive Virtual Reality to Improve Visual Perception and Driving Performance: a Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Jan 2023
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Stroke
- NCT number
- NCT05703360
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Feb 2025 to the primary completion date, 1 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recreational or medicinal consumption of psychoactive drugs.
- Prior/current vision rehabilitation interventions.
Other illness
- Cognitive/motor condition incompatible with driving simulator and/or VR.
- History of vertigo or dizziness.
- Photosensitive epilepsy.
Other
- Both eyes with media opacity that impairs visual field testing.
- Inability to perform during testing and training.
- 3 consecutive VRISE scores \< 25 at inclusion.
- Visual neglect.
Who the study is looking for
- 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.
Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| KITE Research Institute, UHN Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.