Functional Vision in TBI

Study Overview
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Brief Summary
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The objective of this study is to test functional vision outcome measures that reflect the loss in everyday life tasks that require vision and that are sensitive to changes after a course of vision rehabilitation in Veterans/participants with TBI.

Detailed Description
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Traumatic brain injury (TBI) can cause vision loss because of diffuse or focal neuronal injury. Vision can be compromised because of local injury to one or both optic nerves, diffuse brain injury, and/or limitation in eye movements because of dysfunction of cranial nerves. These typical injuries may compromise any of the neural pathways that subserve afferent or efferent visual function. Self-reports of vision loss include diplopia, visual field loss, light sensitivity, reading problems and contrast sensitivity (color and luminance) loss. This project will pursue the following aims: 1) Identify the relationship between functional vision loss in everyday vision tasks (reading, visual search, way finding) and the characteristics of potential visual impairment (visual acuity, contrast sensitivity, visual fields, stereoacuity, eye movement disorders) associated with TBI; and 2) Determine the ability of the vision rehabilitation interventions (both monotherapy and combination therapy) to improve functional vision outcome measures that reflect everyday visual tasks. The vision rehabilitation interventions incorporated into this study will be Vision Restoration Therapy, NVT Eye Scanning Therapy, and standard Eccentric Viewing Training. These therapies are rehabilitative interventions prescribed for Veterans in Polytrauma Rehabilitation Centers, Blind Rehabilitation Centers, and advocated for VA Medical Center TBI clinics.

Official Title
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Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Conditions
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Brain Injuries, Visually Impaired Persons

Intervention / Treatment
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* Other: Vision Restoration Therapy
* Behavioral: NVT Eye Scanning Therapy
* Behavioral: Eccentric Viewing Training
* Behavioral: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TBI (any form) Hemianopic Visual Field Loss Stable fixation 1.0 logMAR or better Reading Acuity 20 words per minute or better reading rate Exclusion Criteria: Visual Neglect medical conditions that prevent sitting for 30 minutes or following instructions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Group 1 - Combination Treatment | Other: Vision Restoration Therapy<br>* Therapy that enhances the neuronal plasticity of the visual system<br>Behavioral: NVT Eye Scanning Therapy<br>* Therapy that trains eye and head scanning into the blind hemianoptic visual field<br>|
| Active Comparator: Arm 2<br>Group 2 - Combination Treatment | Behavioral: Eccentric Viewing Training<br>* Therapy that trains the person to compensate for visual field loss by learning to move the visual field loss to the position that is least likely to impact the current visual task<br>|
| Active Comparator: Arm 3<br>Group 3 - Combination Treatment | Other: Vision Restoration Therapy<br>* Therapy that enhances the neuronal plasticity of the visual system<br>Behavioral: NVT Eye Scanning Therapy<br>* Therapy that trains eye and head scanning into the blind hemianoptic visual field<br>|
| Active Comparator: Arm 4<br>Group 4 - Combination Treatment | Behavioral: Eccentric Viewing Training<br>* Therapy that trains the person to compensate for visual field loss by learning to move the visual field loss to the position that is least likely to impact the current visual task<br>|
| Active Comparator: Arm 5<br>Group 5 - Monotherapy Treatment | Other: Vision Restoration Therapy<br>* Therapy that enhances the neuronal plasticity of the visual system<br>Behavioral: Sham<br>* Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit<br>|
| Active Comparator: Arm 6<br>Group 6 - Monotherapy Treatment | Behavioral: Eccentric Viewing Training<br>* Therapy that trains the person to compensate for visual field loss by learning to move the visual field loss to the position that is least likely to impact the current visual task<br>Behavioral: Sham<br>* Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit<br>|
| Active Comparator: Arm 7<br>Group 7 - Monotherapy Treatment | Behavioral: NVT Eye Scanning Therapy<br>* Therapy that trains eye and head scanning into the blind hemianoptic visual field<br>Behavioral: Sham<br>* Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Visual Field |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Visual Field |  | After First Therapy / Before Second Therapy (Average time is 4.5 months) | 
| Dynamic Visual Field |  | After Second Therapy (Average Time is 9 months) | 
| Reading Rate and Accuracy |  | Baseline | 
| Reading Rate |  | After First Therapy / Before Second Therapy (average time is 4.5 months) | 
| Reading Rate and Accuracy |  | After Second Therapy (average time is 9 months) | 
| Visual Search Accuracy and Timing |  | Baseline | 
| Visual Search Accuracy and Timing |  | After First Therapy / Before Second Therapy (average time is 4.5 months) | 
| Visual Search Accuracy and Timing |  | After Second Therapy (average time is 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Perception, Vision, Ocular, Neuronal Plasticity