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| Name | Class |
|---|---|
| Neuroscience Clinical Trial and Innovation Center (NCTIC) | UNKNOWN |
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The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.
The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilaterally blind Subjects will be exposed to visual-auditory stimulation | Experimental | The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multisensory rehabilitation paradigm | Device | In initial ("training") sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Points Detected at Multiple Locations | To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better") - Visual fields are divided into "affected" areas of the field (detection < 50% on initial testing) and "intact" areas of the field (detection > 50% on initial testing), aggregate data are reported for each at the start and end of study | Month 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Low-vision Visual Functioning Questionnaire (LV-VFQ-48) | information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Rowland, PhD | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Individual Participant Data that underlie the results reported in this article, after deidentification
Beginning 9 months and ending 36 months following article publication
Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation | The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. multisensory rehabilitation paradigm: In initial ("training") sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation | The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. multisensory rehabilitation paradigm: In initial ("training") sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Points Detected at Multiple Locations | To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better") - Visual fields are divided into "affected" areas of the field (detection < 50% on initial testing) and "intact" areas of the field (detection > 50% on initial testing), aggregate data are reported for each at the start and end of study | The high variance in the aggregate statistics at the end of study reflects individual variation in the treatment effect. Significant improvements were observed in 4/5 subjects, no change was observed in 1/5. | Posted | Mean | Standard Deviation | Number of points | Month 3 |
|
3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation | The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. multisensory rehabilitation paradigm: In initial ("training") sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Rowland, MD | Wake Forest University Health Sciences | 704-355-2000 | Benjamin.Rowland@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2021 | Apr 7, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2025 | Nov 20, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D020521 | Stroke |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
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|
| Baseline |
| Low-vision Visual Functioning Questionnaire (LV-VFQ-48) | information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons. | Month 3 |
| Humphrey Visual Field Test | 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. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better) | Baseline |
| Humphrey Visual Field Test | 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. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better) | Month 3 |
| Distance Between Perceived and Actual Stimulus Location | To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better") | Month 3 |
| Reaction Time | To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better") | Month 3 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Low-vision Visual Functioning Questionnaire (LV-VFQ-48) | information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons. | Not Posted | Baseline | Participants |
| Other Pre-specified | Low-vision Visual Functioning Questionnaire (LV-VFQ-48) | information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Humphrey Visual Field Test | 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. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better) | Not Posted | Baseline | Participants |
| Other Pre-specified | Humphrey Visual Field Test | 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. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better) | Not Posted | Month 3 | Participants |
| Other Pre-specified | Distance Between Perceived and Actual Stimulus Location | To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better") | Not Posted | Month 3 | Participants |
| Other Pre-specified | Reaction Time | To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better") | Not Posted | Month 3 | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |