Stroke, IschemicNCT06047717
Vision Loss Impact on Navigation in Virtual Reality
A study testing Virtual Reality Driving Task in people with Stroke, Ischemic and Quadrantanopia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Quadrantanopia, Hemianopsia, Homonymous
- What is being tested?
- Virtual Reality Driving Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Evan Burr, 585-275-5234, Evan_Burr@urmc.rochester.edu
Krystel Huxlin, PhD
About this study
Official title: The Impact of Vision Loss on Naturalistic Behavior and Navigation in Virtual Reality
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).
- Conditions
- Stroke, Ischemic, Quadrantanopia, Hemianopsia, Homonymous, Hemianopia, Homonymous, Hemianopia, Hemianopsia
- Being tested
- Virtual Reality Driving Task
- Keywords
- Occipital stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss, Homonymous quadrantanopsia, Homonymous quadrantanopia, stroke
- Medical subject headings
- Ischemic Stroke, Hemianopsia, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Driving TaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Driving Task: Cortically Blind Cohort | Experimental | 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. Receives: Other: Virtual Reality Driving Task |
| Virtual Reality (VR) Driving Task: Healthy Control Cohort | Experimental | 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. Receives: Other: Virtual Reality Driving Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start28 Nov 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Institute of Technology
- Responsible party
- Principal investigator, Krystel Huxlin, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047717
- Sponsor's protocol ID
- 00008669
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vision Loss on Naturalistic Behavior and Navigation in Virtual Reality
- ClinicalTrials.gov ID
- NCT06047717
- Acronym / sponsor ID
- 00008669
- Conditions
- Stroke, Ischemic, Quadrantanopia, Hemianopsia, Homonymous, Hemianopia, Homonymous, Hemianopia, Hemianopsia
- Keywords
- Occipital stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss, Homonymous quadrantanopsia, Homonymous quadrantanopia, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rochester Institute of Technology
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Driving Task: Cortically Blind Cohort | Experimental | Other: Virtual Reality Driving TaskPersons 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 (VR) Driving Task: Healthy Control Cohort | Experimental | Other: Virtual Reality Driving TaskHealthy 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Driving TaskParticipants 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. | Other | Virtual Reality (VR) Driving Task: Cortically Blind Cohort, Virtual Reality (VR) Driving Task: Healthy Control Cohort |
Primary outcome
Virtual Reality (VR) Lane Deviation / Offset
Time frame: Day 0
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Driving Task in people with Stroke, Ischemic and Quadrantanopia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan Burr (585-275-5234, Evan_Burr@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Reality (VR) Lane Deviation / Offset (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.