NCT06047717

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Nov 2023Oct 2028

First Submitted

Initial submission to the registry

September 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

September 8, 2023

Last Update Submit

January 7, 2026

Conditions

Keywords

Occipital strokeVision loss after strokeVision recoveryVision restorationPartial vision lossHomonymous quadrantanopsiaHomonymous quadrantanopiastroke

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 0

Study Arms (2)

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.

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.

Other: Virtual Reality Driving Task

Interventions

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: Cortically Blind CohortVirtual Reality (VR) Driving Task: Healthy Control Cohort

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeHemianopsiaHemorrhagic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesVision DisordersSensation DisordersNeurologic ManifestationsBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 21, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations