Functional Vision in TBI

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

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.

Study Overview

• Status: Terminated
• Conditions: Brain Injuries; Visually Impaired Persons
• Intervention / Treatment: Other: Vision Restoration Therapy; Behavioral: NVT Eye Scanning Therapy; Behavioral: Eccentric Viewing Training; Behavioral: Sham

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1290
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Group 1 - Combination Treatment	Other: Vision Restoration Therapy; Therapy that enhances the neuronal plasticity of the visual system; Behavioral: NVT Eye Scanning Therapy; Therapy that trains eye and head scanning into the blind hemianoptic visual field
Active Comparator: Arm 2; Group 2 - Combination Treatment	Behavioral: Eccentric Viewing Training; 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
Active Comparator: Arm 3; Group 3 - Combination Treatment	Other: Vision Restoration Therapy; Therapy that enhances the neuronal plasticity of the visual system; Behavioral: NVT Eye Scanning Therapy; Therapy that trains eye and head scanning into the blind hemianoptic visual field
Active Comparator: Arm 4; Group 4 - Combination Treatment	Behavioral: Eccentric Viewing Training; 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
Active Comparator: Arm 5; Group 5 - Monotherapy Treatment	Other: Vision Restoration Therapy; Therapy that enhances the neuronal plasticity of the visual system; Behavioral: Sham; Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
Active Comparator: Arm 6; Group 6 - Monotherapy Treatment	Behavioral: Eccentric Viewing Training; 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; Behavioral: Sham; Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
Active Comparator: Arm 7; Group 7 - Monotherapy Treatment	Behavioral: NVT Eye Scanning Therapy; Therapy that trains eye and head scanning into the blind hemianoptic visual field; Behavioral: Sham; Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dynamic Visual Field	Baseline

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ron Schuchard, PhD, VA Palo Alto Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): November 21, 2013
• Study Completion (Actual): November 21, 2013

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 30, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Neuronal Plasticity; Visual Perception; Vision, Ocular
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: C6687-R