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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
The procedure involves repeatedly presenting identical visual-auditory stimuli at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°). The visual (a 500 ms flash) and auditory (500 ms broadband noise burst) stimuli are in spatial and temporal congruence.
The procedure involves repeatedly presenting identical auditory stimuli (500 ms broadband noise burst) at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°).
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Clinical Ophthalmological Test Scores
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
Time frame: Baseline
Clinical Ophthalmological Test Scores
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
Time frame: Day 15
Clinical Ophthalmological Test Scores
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
Time frame: Week 8
Clinical Ophthalmological Test Scores
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
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Time frame: Week 10
Clinical Ophthalmological Test Scores
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
Time frame: Week 16
Clinical Ophthalmological Test Scores
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
Time frame: Week 48
Clinical Ophthalmological Test Scores
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
Time frame: Week 50
Clinical Ophthalmological Test Scores
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
Time frame: Week 56
Clinical Ophthalmological Test Scores
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
Time frame: Week 64
Visual Perception Test Scores
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).
Time frame: Baseline
Visual Perception Test Scores
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).
Time frame: Day 15
Visual Perception Test Scores
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).
Time frame: Week 8
Visual Perception Test Scores
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).
Time frame: Week 10
Visual Perception Test Scores
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).
Time frame: Week 16
Visual Perception Test Scores
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).
Time frame: Week 48
Visual Perception Test Scores
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).
Time frame: Week 50
Visual Perception Test Scores
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).
Time frame: Week 56
Visual Perception Test Scores
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).
Time frame: Week 64
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Baseline
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Day 15
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 8
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 10
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 16
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 48
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 50
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 56
Functional magnetic resonance imaging (fMRI) scans
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.
Time frame: Week 64
Quality of Life (QoL) Assessment
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
Time frame: Baseline
Quality of Life (QoL) Assessment
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
Time frame: Day 15
Quality of Life (QoL) Assessment
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
Time frame: Week 8
Quality of Life (QoL) Assessment
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
Time frame: Week 10
Quality of Life (QoL) Assessment
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
Time frame: Week 16
Quality of Life (QoL) Assessment
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
Time frame: Week 48
Quality of Life (QoL) Assessment
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
Time frame: Week 50
Quality of Life (QoL) Assessment
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
Time frame: Week 56
Quality of Life (QoL) Assessment
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
Time frame: Week 64