Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-11-28
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Virtual Reality (VR) Driving Task: Cortically Blind Cohort
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.
Virtual Reality Driving Task
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.
Virtual Reality (VR) Driving Task: Healthy Control Cohort
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.
Virtual Reality Driving Task
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.
Interventions
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Virtual Reality Driving Task
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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:
* 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.
21 Years
75 Years
ALL
Yes
Sponsors
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Rochester Institute of Technology
OTHER
University of Rochester
OTHER
Responsible Party
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Krystel Huxlin
James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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00008669
Identifier Type: -
Identifier Source: org_study_id
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