An interventional study of multisensory rehabilitation paradigm in Hemianopia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Basic science
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.
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's enrollment of 5 is below the median of 32 across 53 interventional studies indexed under Hemianopsia.
Browse Hemianopsia studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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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.
Device: 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.
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
Time frame: Month 3
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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: Month 3
Distance Between Perceived and Actual Stimulus Location
To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")
Time frame: Month 3
Reaction Time
To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")
Time frame: Month 3
| Milestone | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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
| Number of points | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| "Affected" Field Start | 14.0 ± 15.1 |
| "Intact" Field Start | 94.9 ± 7.1 |
| "Affected" End of study | 63.6 ± 39.0 |
| "Intact" End of study | 95.4 ± 5.6 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")
Results for this outcome have not been posted.
To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")
Results for this outcome have not been posted.
Collected over 3 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| Mean | 67.6 ± 3.5 |
| Sex: Female, Male(Participants) | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| Female | 1 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual Participant Data that underlie the results reported in this article, after deidentification
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication
Access criteria: 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.
Ran from Sep 2021 to primary completion in Mar 2025, 41 months.
Results were first posted in Apr 2026, 1 year 1 month after primary completion. A results delay was requested in Aug 2023.
Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's 41 months is below that.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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