NCT04230486

VR System for Cross-modal Rehabilitation of Hemianopia

Completed NA Results posted Last updated 30 November 2022

What this trial tests

NA trial testing Cross-model Visual Auditory Rehabilitation in Hemianopia, Homonymous in 6 participants. Completed in 30 July 2021.

Timeline

29 June 2020

Primary endpoint
30 July 2021

30 July 2021

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	29 June 2020
Primary completion	30 July 2021
Estimated completion	30 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Cross-model Visual Auditory Rehabilitation

Conditions studied

• Hemianopia, Homonymous — all drugs for Hemianopia, Homonymous →
• Hemianopsia, Homonymous — all drugs for Hemianopsia, Homonymous →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 99, any sex, with Hemianopia, Homonymous or Hemianopsia, Homonymous. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Humphrey Visual Field Perimetry Primary · Baseline

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 an

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	108	± 198.49
Virtual Reality (VR) Treatment-Intact	1272	± 117.58

Humphrey Visual Field Perimetry Primary · 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 an

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	594	± 542.99
Virtual Reality (VR) Treatment-Intact	1356	± 18.59

Virtual Reality (VR) Visual Field Test--Mean Percent Correct Primary · 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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	91.667	± 11.785

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.33	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 2

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	16.667	± 23.57
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 3

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 4

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 5

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	0	± 0
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 6

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	50	± 70.711
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 7

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	58.333	± 35.355
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 9

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	50	± 70.711
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 10

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	50	± 70.711
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.333	± 11.785
Virtual Reality (VR) Treatment-Intact	100	± 0

Virtual Reality Visual Field Test--Mean Percent Correct Primary · Day 12

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.

15 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	50	± 70.711
Virtual Reality (VR) Treatment-Intact	100	± 0

30 Degrees

Group	Value	95% CI
Virtual Reality (VR) Treatment--Deficit Eye	8.33	± 11.785
Virtual Reality (VR) Treatment-Intact	91.667	± 11.785

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.