Clinical trial NCT04230486: VR System for Cross-modal Rehabilitation of Hemianopia
Official title: Virtual Reality System for Cross-modal Rehabilitation of Hemianopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemianopia, Homonymous
Hemianopsia, Homonymous
Keywords: Hemianopia
Virtual Reality
Rehabilitation
Hemianopsia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants will be given the same treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Humphrey Visual Field Perimetry
timeFrame: Baseline
measure: Humphrey Visual Field Perimetry
timeFrame: up to 2 Months
measure: Virtual Reality (VR) Visual Field Test--Mean Percent Correct
timeFrame: Day 1
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 2
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 3
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 4
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 5
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 6
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 7
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 8
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 9
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 10
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 11
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 12
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 13
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 14
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 15
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 16
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 17
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 18
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 19
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 20
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 21
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 22
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 23
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 24
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 25
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 26
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 27
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 28
measure: Virtual Reality Visual Field Test--Mean Percent Correct
timeFrame: Day 29
measure: Peripheral Visual Field Frame Test
timeFrame: Baseline
measure: Peripheral Visual Field Frame Test
timeFrame: up to 2 Months
measure: Peripheral Visual Field Frame Test
timeFrame: 3 Months
measure: Peripheral Visual Field Frame Test
timeFrame: 6 Months
Secondary outcomes:
measure: National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)--Composite Score
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Composite Score
timeFrame: 6 month
measure: NEI-VFQ-25--General Health Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--General Health Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--General Vision Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--General Vision Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Ocular Pain Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Ocular Pain Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Near Activities Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Near Activities Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Distance Activities Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Distance Activities Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Social Functioning Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Social Functioning Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Mental Health Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Mental Health Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Role Difficulties Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Role Difficulties Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Dependency Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Dependency Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Driving Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Driving Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Color Vision Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Color Vision Score Subscale
timeFrame: 6 months
measure: NEI-VFQ-25--Peripheral Vision Score Subscale
timeFrame: Baseline, 2 months, 3 months
measure: NEI-VFQ-25--Peripheral Vision Score Subscale
timeFrame: 6 months
measure: Veterans Affairs Low Vision Visual Function Questionnaire-48 (VA LV VFQ-48)--Item Score
timeFrame: Baseline, 2 months
measure: VA LV VFQ-48--Item Score
timeFrame: 3 months
measure: VA LV VFQ-48--Item Score
timeFrame: 6 months
measure: VA LV VFQ-48--Composite Score
timeFrame: Baseline, 2 months
measure: VA LV VFQ-48--Composite Score
timeFrame: 3 months
measure: VA LV VFQ-48--Composite Score
timeFrame: 6 months
measure: VA LV VFQ-48--Reading Domain Score
timeFrame: Baseline, 2 months
measure: VA LV VFQ-48--Reading Domain Score
timeFrame: 3 months
measure: VA LV VFQ-48--Reading Domain Score
timeFrame: 6 months
Other outcomes:
measure: Grating Acuity Test
timeFrame: First visit after the completion of rehabilitation (1 or 2 months)
measure: Color Vision Test
timeFrame: First visit after the completion of rehabilitation (1 or 2 months)
measure: Shape Recognition Test
timeFrame: First visit after the completion of rehabilitation (1 or 2 months)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Huai Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: