Effect of Visual Retraining After Stroke

Официальное название

Effect of Visual Retraining on Visual Loss Following Cortical Damage

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Change in Mean Direction Discrimination Threshold [Срок оценки: Baseline to 4-6 months]
• Change in Mean Direction Discrimination Threshold [Срок оценки: Baseline to 8-12 months]
• Change in Mean Direction Integration Threshold [Срок оценки: Baseline to 4-6 months]
• Change in Mean Direction Integration Threshold [Срок оценки: Baseline to 8-12 months]
• Change in Mean Contrast Sensitivity for Direction [Срок оценки: Baseline to 4-6 months]
• Change in Mean Contrast Sensitivity for Direction [Срок оценки: Baseline to 8-12 months]
• Change in Mean Contrast Sensitivity for Static Orientation [Срок оценки: Baseline to 4-6 months]
• Change in Mean Contrast Sensitivity for Static Orientation [Срок оценки: Baseline to 8-12 months]

Вторичные конечные точки (6)

• Humphrey 10-2 and 24-2 perimetry [Срок оценки: Baseline to 4-6 months]
• Humphrey 10-2 and 24-2 perimetry [Срок оценки: Baseline to 8-12 months]
• Goldmann perimetry [Срок оценки: Baseline to 4-6 months]
• Goldmann perimetry [Срок оценки: Baseline to 8-12 months]
• MAIA Visual Field Perimetry [Срок оценки: Baseline to 4-6 months]
• MAIA Visual Field Perimetry [Срок оценки: Baseline to 8-12 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Rochester Medical Center — Rochester

Идентификаторы

NCT: NCT06121219 · STUDY00008697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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