Functional Vision in TBI

NCT ID: NCT01214070

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2013-11-21

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.

Conditions

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Brain Injuries Visually Impaired Persons

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

Group 1 - Combination Treatment

Group Type ACTIVE_COMPARATOR

Vision Restoration Therapy

Intervention Type OTHER

Therapy that enhances the neuronal plasticity of the visual system

NVT Eye Scanning Therapy

Intervention Type BEHAVIORAL

Therapy that trains eye and head scanning into the blind hemianoptic visual field

Arm 2

Group 2 - Combination Treatment

Group Type ACTIVE_COMPARATOR

Eccentric Viewing Training

Intervention Type BEHAVIORAL

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

Arm 3

Group 3 - Combination Treatment

Group Type ACTIVE_COMPARATOR

Vision Restoration Therapy

Intervention Type OTHER

Therapy that enhances the neuronal plasticity of the visual system

NVT Eye Scanning Therapy

Intervention Type BEHAVIORAL

Therapy that trains eye and head scanning into the blind hemianoptic visual field

Arm 4

Group 4 - Combination Treatment

Group Type ACTIVE_COMPARATOR

Eccentric Viewing Training

Intervention Type BEHAVIORAL

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

Arm 5

Group 5 - Monotherapy Treatment

Group Type ACTIVE_COMPARATOR

Vision Restoration Therapy

Intervention Type OTHER

Therapy that enhances the neuronal plasticity of the visual system

Sham

Intervention Type BEHAVIORAL

Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Arm 6

Group 6 - Monotherapy Treatment

Group Type ACTIVE_COMPARATOR

Eccentric Viewing Training

Intervention Type BEHAVIORAL

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

Sham

Intervention Type BEHAVIORAL

Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Arm 7

Group 7 - Monotherapy Treatment

Group Type ACTIVE_COMPARATOR

NVT Eye Scanning Therapy

Intervention Type BEHAVIORAL

Therapy that trains eye and head scanning into the blind hemianoptic visual field

Sham

Intervention Type BEHAVIORAL

Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Interventions

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Vision Restoration Therapy

Therapy that enhances the neuronal plasticity of the visual system

Intervention Type OTHER

NVT Eye Scanning Therapy

Therapy that trains eye and head scanning into the blind hemianoptic visual field

Intervention Type 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

Intervention Type BEHAVIORAL

Sham

Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Schuchard, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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C6687-R

Identifier Type: -

Identifier Source: org_study_id

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