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Vision Loss Impact on Navigation in Virtual Reality

Primary Purpose

Stroke, Ischemic, Quadrantanopia, Hemianopsia, Homonymous

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Driving Task
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke, Ischemic focused on measuring Occipital stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss, Homonymous quadrantanopsia, Homonymous quadrantanopia, stroke

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Cortically Blind Group: Inclusion Criteria: Residents of the United States or Canada Presence of one-sided stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans) Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry. Willing, able, and competent to provide their own informed consent Cognitively able, responsible to understand written and oral instructions in English Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: Those who have never driven or earned a drivers' license Past or present ocular disease interfering with visual acuity Best corrected visual acuity (BCVA) worse than 20/40 in either eye Sustained damage to the dorsal lateral geniculate nucleus Presence of diffuse, whole-brain degenerative processes Presence of brain damage deemed by study staff to potentially interfere with outcome measures History of traumatic brain injury Documented history of drug/alcohol abuse Diagnosis of cognitive or seizure disorders Diagnosis of one-sided attentional neglect Control Group: Inclusion Criteria: Normal or corrected-to-normal vision, who are between the ages of 21 and 75 years of age, roughly matched to the age of CB subjects enrolled above Competent and responsible, as determined by the Principal Investigator Willing, able, and competent to provide their own informed consent Normal cognitive abilities, be able to understand written and oral instructions in English Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: Subjects who have never driven or earned a drivers' license BCVA worse than 20/40 in either eye Presence of vision loss from ocular diseases or disorders Presence of a visual field defect Inability to wear corrective contact lenses inside the virtual reality helmet if required to see clearly Subjects with a history of neurological disorders Subjects with a history of TBI Persons who lack the competence or are otherwise unable to perform the visual testing as directed.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Virtual Reality (VR) Driving Task: Cortically Blind Cohort

Virtual Reality (VR) Driving Task: Healthy Control Cohort

Arm Description

Persons who have sustained cortical blindness will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.

Healthy controls with no vision loss will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.

Outcomes

Primary Outcome Measures

Virtual Reality (VR) Lane Deviation / Offset
Virtual lane offset is a measure of driving accuracy, which involves computing the divergence (in virtual meters) from the center of the single-lane virtual roadway, relative to the position of the driver's head and averaged over the duration of each turn. The researchers will compare the variance of lane offset in virtual meters between Cortically Blind (CB) and control subjects.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 22, 2023
Sponsor
University of Rochester
Collaborators
Rochester Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT06047717
Brief Title
Vision Loss Impact on Navigation in Virtual Reality
Official Title
The Impact of Vision Loss on Naturalistic Behavior and Navigation in Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Rochester Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving. Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Quadrantanopia, Hemianopsia, Homonymous, Hemianopia, Homonymous, Hemianopia, Hemianopsia, Occipital Lobe Infarct, Visual Field Defect, Peripheral, Vision Loss Partial, Quadrantanopsia, Stroke Hemorrhagic
Keywords
Occipital stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss, Homonymous quadrantanopsia, Homonymous quadrantanopia, stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR) Driving Task: Cortically Blind Cohort
Arm Type
Experimental
Arm Description
Persons who have sustained cortical blindness will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.
Arm Title
Virtual Reality (VR) Driving Task: Healthy Control Cohort
Arm Type
Experimental
Arm Description
Healthy controls with no vision loss will perform a driving task in VR, in which they must steer through a series of parameterized turns while maintaining their virtual vehicle centered between the two red lines delineating the "road" edge.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Driving Task
Intervention Description
Participants will steer a virtual car with the goal of staying in the center of a single-lane roadway while traveling at a constant speed of 26.6 m/s (approximately 60 miles/hr). The roadway alternates between a series of straights and turns of different radii to both the left and the right. This allows for careful control of task difficulty, and for the repeated presentation of specific conditions across multiple "trials" (i.e. turns in the road) in a randomized order. In addition, the density of the visual texture elements in the virtual environment that provide optic flow (OF) signal is also varied. The low-density OF condition has no road texture or foliage, and only the solid road edges on a flat-black ground plane. The medium-density OF condition has sparse textural elements distributed on the ground plane, and the high-density OF condition has high density road texture and a canopy of road-side trees that provide texture extending far above the horizon.
Primary Outcome Measure Information:
Title
Virtual Reality (VR) Lane Deviation / Offset
Description
Virtual lane offset is a measure of driving accuracy, which involves computing the divergence (in virtual meters) from the center of the single-lane virtual roadway, relative to the position of the driver's head and averaged over the duration of each turn. The researchers will compare the variance of lane offset in virtual meters between Cortically Blind (CB) and control subjects.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Cortically Blind Group: Inclusion Criteria: Residents of the United States or Canada Presence of one-sided stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans) Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry. Willing, able, and competent to provide their own informed consent Cognitively able, responsible to understand written and oral instructions in English Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: Those who have never driven or earned a drivers' license Past or present ocular disease interfering with visual acuity Best corrected visual acuity (BCVA) worse than 20/40 in either eye Sustained damage to the dorsal lateral geniculate nucleus Presence of diffuse, whole-brain degenerative processes Presence of brain damage deemed by study staff to potentially interfere with outcome measures History of traumatic brain injury Documented history of drug/alcohol abuse Diagnosis of cognitive or seizure disorders Diagnosis of one-sided attentional neglect Control Group: Inclusion Criteria: Normal or corrected-to-normal vision, who are between the ages of 21 and 75 years of age, roughly matched to the age of CB subjects enrolled above Competent and responsible, as determined by the Principal Investigator Willing, able, and competent to provide their own informed consent Normal cognitive abilities, be able to understand written and oral instructions in English Emmetropic or else wear corrective contact lenses inside the virtual reality headset Exclusion Criteria: Subjects who have never driven or earned a drivers' license BCVA worse than 20/40 in either eye Presence of vision loss from ocular diseases or disorders Presence of a visual field defect Inability to wear corrective contact lenses inside the virtual reality helmet if required to see clearly Subjects with a history of neurological disorders Subjects with a history of TBI Persons who lack the competence or are otherwise unable to perform the visual testing as directed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrys Callan
Phone
585-276-3426
Email
Christine_Callan@URMC.Rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Vision Loss Impact on Navigation in Virtual Reality

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