Ameliorating Stroke-induced Hemianopia Via Multisensory Training
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hemianopia, Homonymous
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual Perception Test Scores
- 状态
- 尚未招募
- 最后更新
- 7个月前
概览
简要总结
This study seeks to determine the extent of the visual capabilities that can be restored in hemianopic stroke patients by a multisensory training technique and evaluate changes in the brain that the training induces. The effectiveness of the technique will be evaluated in two interventional contexts: patients whose blindness is long-standing and stable, and another in which intervention is as soon as possible after the stroke.
详细描述
The aims of the study are to: 1\. To identify the visual capabilities and neural circuits in stroke patients with stable hemianopia (\>6 months) that recover after regular multisensory (vs. unisensory) training sessions. This involves: 1A. Using clinical ophthalmological tests and visual perceptual tests to evaluate the visual capabilities that are recovered. 1B. Determining whether the size or extent of cortical lesions are predictive of changes induced by the training technique, and tracking changes in the residual visual circuits using functional magnetic resonance imaging (fMRI). 1C. Determining if the training-induced changes improve, persist, or degrade over time by re-assessment at a 12-month followup. 2\. Evaluate the effectiveness of an earlier (\<1 month post-stroke) and more intense training intervention strategy using the above approach and comparing the outcomes in these two approaches.
研究者
入排标准
入选标准
- •Age \>= 18 years old
- •Homonymous hemianopia diagnosed and referred by a neurologist, confirmed with Humphrey test (Goldmann size V) on first visit. Hemianopia must have been evident for at least 6 months for inclusion in the first experiment and \<1 month for inclusion in the second
- •Cognitively normal, defined as having normal activities of daily living OR has received a cognitive adjudication of normal through the Wake Forest University School of Medicine or equivalent within the past 12 months
- •MRI compatible
- •Has reliable transportation or is able to use transportation provided by the study
- •English speaking
排除标准
- •Current major medical problems that might independently affect cognition, vision, or interfere with ability to attend study visits. This includes pathology of the retina or optic nerve explanatory of blindness
- •Unable or unwilling to attend scheduled testing and training sessions, including the 12 month follow up
- •Current diagnosis of a major neurological disorder that could interfere with the ability to follow task instructions (Dementia, Parkinson's disease, etc.) or that may interfere with the rehabilitation paradigm (uncorrected asymmetric hearing loss, deafness, hemineglect)
- •Unwilling or unable to provide consent for study participation
- •Current stroke symptoms deemed exclusionary by a study physician. This will be reviewed on a case-by-case basis by a study physician to determine whether factors may affect study outcomes, aims, or integrity
- •Taking medication that could negatively influence safety during the intervention
- •Enrolled in another interventional research study \<= 3 months prior to beginning this study
- •Self-reports regularly drinking \> 14 alcoholic beverages a week or current illicit drug use
结局指标
主要结局
Visual Perception Test Scores
时间窗: Week 64
Ability to detect and discriminate different visual features - The participant is asked to indicate (via button press) whether the test stimulus matches the sample (left button), does not match the sample (right button), or there was no test stimulus (withhold response).
Quality of Life (QoL) Assessment
时间窗: Week 64
The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA-LV-VFQ-48) - A higher score on the VA LV VFQ-48 indicates better ability or less difficulty in performing activities
Functional magnetic resonance imaging (fMRI) scans
时间窗: Week 64
Used to measure functional lesion and assess changes - fMRI enables the detection of abnormalities of the brain, as well as the assessment of the normal functional anatomy of the brain, which cannot be accomplished with other imaging techniques.
Clinical Ophthalmological Test Scores
时间窗: Week 64
Humphrey tests - The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a certain spot. A normal visual field extends approximately 100° temporally (laterally), 60° nasally, 60° superiorly, and 70° inferiorly. A normal visual field measures about: 90 degrees temporally. 50 degrees superiorly and nasally. 60 degrees inferiorly