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

Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

• Устройство 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 o

Первичные конечные точки

• Changes from baseline in braking response (sec) [Срок оценки: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
• Changes from baseline in collisions (total #) [Срок оценки: 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) [Срок оценки: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
• Changes from baseline in speed variability (km/h) [Срок оценки: 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) [Срок оценки: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]

Вторичные конечные точки (5)

• Changes from baseline in visual attention and speed using Re:ViewD [Срок оценки: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
• Changes from baseline in visual fields [Срок оценки: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)]
• Simulator Sickness Questionnaire (SSQ) [Срок оценки: 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 [Срок оценки: Initial visit (day 0)]
• Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period [Срок оценки: Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 2 центра

• KITE Research Institute, UHN — Toronto
• Toronto Western Hospital — Toronto

Публикации

• 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
• 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

Идентификаторы

NCT: NCT05703360 · 22-5914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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