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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intervention: Multisensory Training | Experimental | Patients with stable hemianopia (>6 months) are given multisensory training |
|
| Standard Intervention: Unisensory Training | Active Comparator | Patients with stable hemianopia (>6 months) are given auditory training and crossover to multisensory training |
|
| Early Intervention: Multisensory Training | Experimental | Patients with early hemianopia (<1 months) are given multisensory training |
|
| Early Intervention: Unisensory Training | Active Comparator | Patients with early hemianopia (<1 months) are given auditory training and crossover to multisensory training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multisensory Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin A Rowland, PhD | Contact | 336-716-7096 | benjamin.rowland@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin A Rowland, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
Published data from the project will be made available to other researchers via the NIMH NDA repository. This may or may not include IPD.
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D019575 | Blindness, Cortical |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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There are two principal sub-studies: standard intervention and early intervention. Each sub-study contains a multisensory training group (experimental arm) and a unisensory training group (control arm). The unisensory training group crosses over to multisensory training at its completion. Thus, the model design is both factorial and crossover.
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The experimental and control paradigms are based on sensory stimulation and there is no practical way to mask the participant from its nature, although they are not informed as to what the expected results will be. The outcomes assessor will be blinded to which stimulation arm preceded the data collection.
|
| Unisensory Training | Behavioral | 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°). |
|
| 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 | 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 | 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 | 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 | 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 | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 64 |
| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |