Multisensory Rehabilitation of Hemianopia

NCT ID: NCT04963075

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemianopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

multisensory rehabilitation paradigm

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Neuroscience Clinical Trial and Innovation Center (NCTIC)

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Rowland, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00074687

Identifier Type: -

Identifier Source: org_study_id

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