VR System for Cross-modal Rehabilitation of Hemianopia

NCT04230486 | Completed Results FDA Device

• 1 other identifier: IRB00061542
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemianopia, Homonymous; Hemianopsia, Homonymous

Keywords

Hemianopia; Virtual Reality; Rehabilitation; Hemianopsia

Outcome Measures

Primary Outcomes (35)

• Humphrey Visual Field Perimetry

  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.

  Baseline

• Humphrey Visual Field Perimetry

  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.

  up to 2 Months

• Virtual Reality (VR) Visual Field Test--Mean Percent Correct

  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.

  Day 1

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 2

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 3

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 4

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 5

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 6

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 7

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 8

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 9

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 10

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 11

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 12

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 13

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 14

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 15

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 16

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 17

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 18

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 19

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 20

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 21

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 22

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 23

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 24

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 25

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 26

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 27

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 28

• Virtual Reality Visual Field Test--Mean Percent Correct

  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.

  Day 29

• Peripheral Visual Field Frame Test

  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.

  Baseline

• Peripheral Visual Field Frame Test

  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.

  up to 2 Months

• Peripheral Visual Field Frame Test

  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.

  3 Months

• Peripheral Visual Field Frame Test

  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.

  6 Months

Secondary Outcomes (35)

• National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score

  Baseline, 2 months, 3 months

• NEI-VFQ-25--Composite Score

  6 month

• NEI-VFQ-25--General Health Score Subscale

  Baseline, 2 months, 3 months

• NEI-VFQ-25--General Health Score Subscale

  6 months

• NEI-VFQ-25--General Vision Score Subscale

  Baseline, 2 months, 3 months

Other Outcomes (3)

• Grating Acuity Test

  First visit after the completion of rehabilitation (1 or 2 months)

• Color Vision Test

  First visit after the completion of rehabilitation (1 or 2 months)

• Shape Recognition Test

  First visit after the completion of rehabilitation (1 or 2 months)

Study Arms (1)

Experimental Group Virtual Reality (VR) Treatment

EXPERIMENTAL

Visual Auditory Virtual Reality rehabilitation for visual hemianopia

Device: Cross-model Visual Auditory Rehabilitation

Interventions

Cross-model Visual Auditory Rehabilitation DEVICE

Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.

Experimental Group Virtual Reality (VR) Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Huai Jiang, PhD
• Organization: Wake Forest School of Medicine

jianghuai.ws@gmail.com

336-695-6460

Study Officials

• Huai Jiang, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants will be given the same treatment.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: June 29, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available immediately following publication for five years.
• Access Criteria: Anyone who wishes to access the data for any purpose.

Locations

US (1)