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Completed

NCT Number: NCT04963075

Multisensory Rehabilitation of Hemianopia

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.

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Key information

Conditions

Hemianopia Blindness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Eye Diseases Hemianopsia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stroke Vascular Diseases Vision Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults (<85) of either sex
  • diagnosis of a stable homonymous hemianopia (>6 months) with absence of hemineglect
  • lesion encompassing at least primary visual cortex but sparing parietal cortex
  • normal auditory and cognitive function
  • willingness to participate in the three month program
  • ability to perform the visual discriminations in their intact field

Exclusion criteria

  • adults (>85)
  • normal auditory and cognitive function
  • unwilling to participate in the three month program
  • inability to perform the visual discriminations in their intact field

Treatment and study plan

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.

Primary outcomes

  1. Number of Points Detected at Multiple Locations

    Time frame: Month 3

    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

Other outcomes

  1. Low-vision Visual Functioning Questionnaire (LV-VFQ-48)

    Time frame: Baseline

    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.

  2. Low-vision Visual Functioning Questionnaire (LV-VFQ-48)

    Time frame: Month 3

    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.

  3. Humphrey Visual Field Test

    Time frame: Baseline

    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)

  4. Humphrey Visual Field Test

    Time frame: Month 3

    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)

  5. Distance Between Perceived and Actual Stimulus Location

    Time frame: Month 3

    To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")

  6. Reaction Time

    Time frame: Month 3

    To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Neuroscience Clinical Trial and Innovation Center (NCTIC)

Registry information

Official study title

Non-Invasive Multisensory Rehabilitation of Hemianopia

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2021
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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