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Recruiting NCT06121219

Effect of Visual Retraining After Stroke

No phase Interventional Vision Loss Partial Vision; Loss, Both Eyes Hemianopia Homonymous Hemianopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training in the Blind Field.
Who it may be relevant to
Registry conditions: Vision Loss Partial, Vision; Loss, Both Eyes, Hemianopia Homonymous, Hemianopia. Basic parameters: 21 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Visual Retraining on Visual Loss Following Cortical Damage

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Change in Mean Direction Discrimination Threshold [Time frame: Baseline to 4-6 months]
  • Change in Mean Direction Discrimination Threshold [Time frame: Baseline to 8-12 months]
  • Change in Mean Direction Integration Threshold [Time frame: Baseline to 4-6 months]
  • Change in Mean Direction Integration Threshold [Time frame: Baseline to 8-12 months]
  • Change in Mean Contrast Sensitivity for Direction [Time frame: Baseline to 4-6 months]
  • Change in Mean Contrast Sensitivity for Direction [Time frame: Baseline to 8-12 months]
  • Change in Mean Contrast Sensitivity for Static Orientation [Time frame: Baseline to 4-6 months]
  • Change in Mean Contrast Sensitivity for Static Orientation [Time frame: Baseline to 8-12 months]
Secondary outcome measures (6)
  • Humphrey 10-2 and 24-2 perimetry [Time frame: Baseline to 4-6 months]
  • Humphrey 10-2 and 24-2 perimetry [Time frame: Baseline to 8-12 months]
  • Goldmann perimetry [Time frame: Baseline to 4-6 months]
  • Goldmann perimetry [Time frame: Baseline to 8-12 months]
  • MAIA Visual Field Perimetry [Time frame: Baseline to 4-6 months]
  • MAIA Visual Field Perimetry [Time frame: Baseline to 8-12 months]

Eligibility criteria

Cortically Blind Subjects

Inclusion:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Rochester Medical Center — Rochester

Identifiers

NCT: NCT06121219 · STUDY00008697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗