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Multisensory Rehabilitation of Hemianopia

Primary Purpose

Hemianopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multisensory rehabilitation paradigm
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hemianopia focused on measuring visual cortex injury, stroke, blindness, cortical damage

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unilaterally blind Subjects will be exposed to visual-auditory stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of points detected
To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better")
Reaction time
To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")
Distance between perceived and actual stimulus location
To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")
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.
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.
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)
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)

Secondary Outcome Measures

Full Information

First Posted
July 6, 2021
Last Updated
August 3, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Neuroscience Clinical Trial and Innovation Center (NCTIC)
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1. Study Identification

Unique Protocol Identification Number
NCT04963075
Brief Title
Multisensory Rehabilitation of Hemianopia
Official Title
Non-Invasive Multisensory Rehabilitation of Hemianopia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Neuroscience Clinical Trial and Innovation Center (NCTIC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia
Keywords
visual cortex injury, stroke, blindness, cortical damage

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilaterally blind Subjects will be exposed to visual-auditory stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
multisensory rehabilitation paradigm
Intervention Description
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 Outcome Measure Information:
Title
Number of points detected
Description
To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better")
Time Frame
3 months
Title
Reaction time
Description
To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")
Time Frame
3 months
Title
Distance between perceived and actual stimulus location
Description
To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")
Time Frame
3 months
Title
Low-vision visual functioning questionnaire (LV-VFQ-48)
Description
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
Title
Low-vision visual functioning questionnaire (LV-VFQ-48)
Description
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
Title
Humphrey visual field test
Description
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
Title
Humphrey visual field test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Rowland, PhD
Phone
336-716-7096
Email
browland@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cara Everhart
Phone
336-716-5371
Email
ceverhar@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Rowland, PhD
Organizational Affiliation
Wake Forest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Rowland, PhD
Phone
336-716-7096
Email
browland@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data that underlie the results reported in this article, after deidentification
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing 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.

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Multisensory Rehabilitation of Hemianopia

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