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Behavioural Intervention

AV-Stimulation in VR for Vision Impairment (Re:DriVR Trial)

N/A

Waitlist Available

Led By Jennifer Campos, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Visual field defects due to TBI or stroke

Be older than 18 years old

Must not have

Prior/current vision rehabilitation interventions

Inability to perform during testing and training

Timeline

Screening 3 weeks

Treatment Varies

Follow Up initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a 6-week VR-based program can improve driving performance in people who have lost their license due to vision issues. #ClinicalTrial #VR #DrivingPerfomance

Who is the study for?

This trial is for adults over 25 who've lost their driver's license due to vision problems from a stroke or brain injury. They must have had a valid license, be able to follow the program, pass an online hearing test, and have home Wi-Fi. People with certain cognitive conditions, drug use, vertigo, prior vision therapy, severe visual neglect or epilepsy can't join.

What is being tested?

The study tests if a 6-week immersive VR program can improve visual perception and driving skills in people with vision loss. Participants are split into two groups: one starts training immediately and the other waits six weeks before starting. Their driving performance and visual abilities are tested before, halfway through, and after the program.

What are the potential side effects?

Potential side effects aren't specified but may include discomfort from VR such as dizziness or nausea especially in individuals prone to motion sickness or those with pre-existing vestibular disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have vision problems because of a brain injury or stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone vision rehabilitation.

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I cannot perform tasks during tests and training.

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I have experienced vertigo or dizziness in the past.

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Both of my eyes have a condition that affects my vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)

This trial's timeline: 3 weeks for screening, Varies for treatment, and initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes from baseline in braking response (sec)

Changes from baseline in collisions (total #)

Changes from baseline in lane keeping (meters of deviations/departures)

+2 more

Secondary study objectives

Changes from baseline in visual attention and speed using Re:ViewD

Changes from baseline in visual fields

Simulator Sickness Questionnaire (SSQ)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist GroupExperimental Treatment1 Intervention

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.

Group II: VR Intervention FirstExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Audiovisual Stimulation

2019

N/A

~110

0 / 5Eligibility criteria met