Visual Rehabilitation After Occipital Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Direction Discrimination Threshold
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Direction Discrimination Threshold
时间窗: baseline, 6 months, 12 months
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.
次要结局
- Direction Integration Threshold(baseline, 6 months, 12 months)
- Ganglion cell complex volume laterality(baseline, 6 months, 12 months)
- contrast sensitivity for static orientation(baseline, 6 months, 12 months)
- Optic Tract (OT) laterality(baseline, 6 months, 12 months)
- Ganglion cell complex thickness laterality(baseline, 6 months, 12 months)
- Contrast Sensitivity for Direction(baseline, 6 months, 12 months)
研究者
Krystel Huxlin
James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology
University of Rochester