VR System for Cross-modal Rehabilitation of Hemianopia

Not Applicable

Completed

• Conditions: Hemianopsia, Homonymous; Hemianopia, Homonymous
• Interventions: Device: Cross-model Visual Auditory Rehabilitation

• Registration Number: NCT04230486
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this research study is to investigate the effectiveness of a new rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation technique delivered by a virtual reality system can help restore the visual field for subjects with homonymous hemianopia.

Detailed Description

The study tests a novel rehabilitation system, translated from promising cross-modal rehabilitation animal research, that is the first treatment capable of restoring the visual field for hemianopia patients. This noninvasive technique uses a virtual reality device to deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept and procure rehabilitation data to support the development of this novel rehabilitation treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-06-29
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-02
• Results First Submitted: 2022-07-29
• Results First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Results First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)

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Exclusion Criteria

• Volunteers who are unable to complete the study tasks or understand instructions
• Subjects that are not able to provide written consent or verbal assent
• Subjects who are not available to complete all rehabilitation sessions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group Virtual Reality (VR) Treatment	Cross-model Visual Auditory Rehabilitation	Visual Auditory Virtual Reality rehabilitation for visual hemianopia

Primary Outcome Measures

Name	Time	Method
Humphrey Visual Field Perimetry	up to 2 Months	The area of the subject's visual field measured by 30-2 Humphrey visual field (HVF) perimetry. Both left and right sides will be tested. The deficit side includes is the hemianopic side. The intact side is the non-hemianopic side. During the HVF test, light is projected into a white bowl with a standardized background light intensity to form a circular stimulus, around 30 cm away from the patient's eye. The overall field mapping technique used is a form of static perimetry, where a stimulus appears in various areas of the field of vision. The patient indicates when they can see the stimulus and the perimetrist then records the point where the stimulus was seen. These data points are used to determine the patient's visual field.
Virtual Reality Visual Field Test--Mean Percent Correct	Day 29	Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.
Virtual Reality (VR) Visual Field Test--Mean Percent Correct	Day 1	Percent of correct trials in each location tested. Location at 15 degrees and 30 degrees on the horizontal meridian on both the left and right side were tested. Virtual Reality Visual Field test is a brief 5-minute test using the VR system to track rehabilitation progress. The test consists of 30 trials with visual stimulus presented either 15° or 30° in either the hemianopia field or the intact field at random time intervals.
Peripheral Visual Field Frame Test	6 Months	The number of points subjects can detect in each location of the visual field along the horizontal meridian. Percent of correct trials in each location tested in the deficit and intact side. Locations at 15°, 30°, 45°, 60°, and 75° on the horizontal meridian on the left and right side were tested.

Secondary Outcome Measures

Name	Time	Method
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score	Baseline, 2 months, 3 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life.
NEI-VFQ-25--General Vision Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Vision Score measures the participant's reported quality of vision. The score ranges from 0 to 100. A higher score denotes a better perception of vision
NEI-VFQ-25--General Health Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The General Health Score is a subscale that measures the participant's self-report of their overall health. The score ranges from 0 to 100. A higher score denotes better perception of overall health.
NEI-VFQ-25--Near Activities Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Near Activities Score Subscale measures difficulty with performing near activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to near activities.
NEI-VFQ-25--Peripheral Vision Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Peripheral Vision Score Subscale measures how much difficulty patients have with their peripheral vision to complete daily activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to peripheral vision.
VA LV VFQ-48--Composite Score	6 months	he VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is \<= 2.34 and \>=-2.22. Scores out of this range indicate something other than visual impairment is governing the patient's responses. The reading domain score is calculated by calculating the average score of reading items. The composite score approximates a person's visual ability. The score is calculated using Massof's algorithm using the inverse hyperbolic tangent equation. For the composite score, a lower score is better.
NEI-VFQ-25--Role Difficulties Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Role Difficulties Score Subscale measures how limited by their vision patients feel they are. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to role difficulties.
NEI-VFQ-25--Composite Score	6 month	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. This score is calculated from the average of all subscale scores in the NEI VFQ-25 excluding the general health score. The score ranges from 0 to 100. A higher score denotes better vision-related quality of life.
NEI-VFQ-25--Ocular Pain Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Ocular Pain Score Subscale measures reported pain or discomfort in and around the eyes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to ocular pain.
NEI-VFQ-25--Social Functioning Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Social Functioning Score Subscale measures how vision difficulties affect social functioning. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to social functioning.
NEI-VFQ-25--Dependency Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Dependency Score Subscale measures how much patients are dependent on other people due to their vision. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to dependency.
NEI-VFQ-25--Driving Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Driving Score Subscale measures patients' reported difficulty with driving. The score ranges from 0 to 100. Patients who do not drive are not given a driving score. A higher score denotes better vision-specific quality of life related to driving.
Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score	Baseline, 2 months	The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is \<= 2.34 (most difficult) and \>=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity.
NEI-VFQ-25--Distance Activities Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Distance Activities Score Subscale measures difficulty with performing distance activities. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to distance activities.
NEI-VFQ-25--Color Vision Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Color Vision Score Subscale measures how much difficulty patients have with using color vision to complete daily activities such as picking out clothes. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life related to color vision.
VA LV VFQ-48--Item Score	6 months	The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The acceptable range for the average item score is \<= 2.34 (most difficult) and \>=-2.22 (least difficult). Scores out of this range indicate something other than visual impairment is governing the patient's responses. The Item Score is the average functional reserve of all the items in the questionnaire excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons). Functional reserve is the difference between a patient's visual ability and the visual ability needed to perform an activity.
VA LV VFQ-48--Reading Domain Score	6 months	The VA LV VFQ-48 is a self-report instrument designed to measure difficulty visually impaired persons have performing daily activities. The reading domain score is calculated by calculating the average score of reading items. Scores range from 0 to 3.5 logits, with higher scores denoting better ability to perform activities. The Reading Domain Score is the average functional reserve of the items measuring the reading functional domain, excluding items which were rated Unscored (Difficult / don't do for Non-Visual Reasons).
NEI-VFQ-25--Mental Health Score Subscale	6 months	The NEI-VFQ-25 is a 25-item questionnaire regarding the quality of vision, social functioning, visual dependency, near vision, and color vision. The Mental Health Score Subscale measures how much patients feel vision affects their mental health. The score ranges from 0 to 100. A higher score denotes better vision-specific quality of life relating to mental health.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States