Trial Outcomes & Findings for Multisensory Rehabilitation of Hemianopia (NCT NCT04963075)
NCT ID: NCT04963075
Last Updated: 2026-04-30
Results Overview
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
COMPLETED
NA
5 participants
Month 3
2026-04-30
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multisensory Rehabilitation of Hemianopia
Baseline characteristics by cohort
| Measure |
Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation
n=5 Participants
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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Age, Continuous
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67.6 years
STANDARD_DEVIATION 3.5 • n=14 Participants
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Sex: Female, Male
Female
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1 Participants
n=14 Participants
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Sex: Female, Male
Male
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4 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=14 Participants
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Race (NIH/OMB)
White
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4 Participants
n=14 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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PRIMARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation
n=5 Participants
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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Number of Points Detected at Multiple Locations
"Affected" Field Start
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14.0 Number of points
Standard Deviation 15.1
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Number of Points Detected at Multiple Locations
"Intact" Field Start
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94.9 Number of points
Standard Deviation 7.1
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Number of Points Detected at Multiple Locations
"Affected" End of study
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63.6 Number of points
Standard Deviation 39.0
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Number of Points Detected at Multiple Locations
"Intact" End of study
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95.4 Number of points
Standard Deviation 5.6
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baselineinformation 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 3information 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe 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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 3The 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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 3To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 3To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")
Outcome measures
Outcome data not reported
Adverse Events
Unilaterally Blind Subjects Will be Exposed to Visual-auditory Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Benjamin Rowland, MD
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place