Effect of Visual Retraining After Stroke

NCT ID: NCT06121219

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2032-01-31

Brief Summary

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

Conditions

Vision Loss Partial; Vision; Loss, Both Eyes; Hemianopia Homonymous; Hemianopia; Quadrantanopia; Stroke, Ischemic; Stroke - Occipital Infarction; Cortical Blindness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Cortically Blind (CB) Subjects

Cortically Blind subjects will be enrolled to perform a daily home visual training task.

Group Type: EXPERIMENTAL

Training in the Blind Field

Intervention Type: DEVICE

A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. Subjects 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, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) 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 3 and up to 12 months at a time.

Normative Comparator: Control Subjects

Healthy control subjects will be recruited to collect normative data by which to compare test results from CB subjects. No home training will be asked.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training in the Blind Field

A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. Subjects 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, the presence of motion, or the orientation of a visual stimulus (either a small cloud of dots or bars) 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 3 and up to 12 months at a time.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between 21 and 80 years of age
• Residents of the United States or Canada
• Unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range (21-75 years)
• Reliable visual field defects in both eyes as measured by Humphrey, MAIA, Goldmann, and/or equivalent perimetry, large enough to enclose a 5-deg diameter visual stimulus.
• Able to fixate on visual targets reliably for 1000ms
• Must have a home computer (desktop or laptop) and reliable internet access
• Willing, able, and competent to provide informed consent
• Normal cognitive abilities, able to understand written and oral instructions in English, and competent and responsible adults in order to complete the visual training at home, independently, as instructed, for several months.

Exclusion:

• Past or present eye disease interfering with visual acuity
• BCVA worse than 20/40 in either eye
• Damage to the dorsal Lateral Geniculate Nucleus
• Diffuse whole brain degenerative processes
• History of traumatic brain injury
• Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
• Documented history of drug/alcohol abuse
• Currently taking neuroactive medications which would impact training, as determined by PI
• Presence of cognitive or seizure disorders
• One-sided attentional neglect
• Subjects who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control Subjects (n = 50)

Inclusion:

• Between 21 and 80 years of age
• Report no history of neurological disorder.
• Competent and responsible, as determined by the Principal Investigator.

Exclusion:

• Presence of damage to the visual system
• Presence of an active disease process involving their nervous system.
• Cognitive or seizure disorders
• Best corrected visual acuity worse than 20/40 in either eye
• Presence of vision field loss from ocular disease or disorder

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Krystel Huxlin

James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan Burr

Role: CONTACT

Evan_Burr@urmc.rochester.edu

585-275-5234

Facility Contacts

Evan Burr, BA

Role: primary

Evan_Burr@URMC.Rochester.edu

585-275-5423

Other Identifiers

STUDY00008697

Identifier Type: -

Identifier Source: org_study_id