Visual Rehabilitation After Occipital Stroke

NCT04798924 | Active Not Recruiting

• 2 other identifiers: 00005966R01EY027314
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.

Conditions

Stroke, Ischemic; Quadrantanopia; Vision Loss Partial; Visual Field Defect, Peripheral; Peripheral Visual Field Defect of Both Eyes; Peripheral Visual Field Defect; Hemianopsia; Hemianopia; Homonymous Hemianopia; Homonymous Hemianopsia; Visual Fields Hemianopsia; Occipital Lobe Infarct; Quadrantanopsia; Stroke Hemorrhagic

Keywords

Occipital stroke; vision loss; Homonymous quadrantanopia; Homonymous quadrantanopsia; stroke; Vision loss after stroke; Vision recovery; Vision restoration; Partial vision loss

Outcome Measures

Primary Outcomes (1)

• Direction Discrimination Threshold

  For each subject, we will measure the ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

  baseline, 6 months, 12 months

Secondary Outcomes (6)

• Direction Integration Threshold

  baseline, 6 months, 12 months

• Contrast Sensitivity for Direction

  baseline, 6 months, 12 months

• contrast sensitivity for static orientation

  baseline, 6 months, 12 months

• Ganglion cell complex thickness laterality

  baseline, 6 months, 12 months

• Ganglion cell complex volume laterality

  baseline, 6 months, 12 months

Other Outcomes (3)

• MAIA Visual Field Perimetry

  baseline, 6 months, 12 months

• Humphrey 10-2 and 24-2 perimetry

  baseline, 6 months, 12 months

• Goldmann perimetry

  baseline, 6 months, 12 months

Study Arms (2)

Training in the blind field

EXPERIMENTAL

Training in the blind field using specialized software

Device: Subacute Training in the blind field; Device: Chronic Training in the blind field

Training in the intact field

EXPERIMENTAL

Training in the intact field using specialized software

Device: Subacute Training in the intact field; Device: Chronic Training in the blind field

Interventions

Subacute Training in the intact field DEVICE

A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the intact field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.

Training in the intact field

Subacute Training in the blind field DEVICE

A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.

Training in the blind field

Chronic Training in the blind field DEVICE

After the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 6 months.

Training in the blind field; Training in the intact field

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents of US and Canada
• MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
• Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
• Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
• Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
• Willing, able, and competent to provide informed consent
• Fluent in written and spoken English
• Cognitively able, responsible, and willing to complete daily visual training independently at home for several months.

You may not qualify if:

• Past or present ocular disease interfering with vision
• Best corrected visual acuity worse than 20/40 in either eye
• Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
• Diffuse, whole brain degenerative processes
• Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
• History of traumatic brain injury
• Documented history of drug/alcohol abuse
• Currently use of neuroactive medications which would impact training, as determined by PI
• Cognitive or seizure disorders
• One-sided attentional neglect
• Inability to perform the visual training exercises as directed

Sponsors & Collaborators

• University of Rochester: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemianopsia; Hemorrhagic Stroke; Vision Disorders; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• 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: February 25, 2021
• First Posted: March 15, 2021
• Study Start: July 19, 2021
• Primary Completion: September 26, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)