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Functional Vision in TBI

Primary Purpose

Brain Injuries, Visually Impaired Persons

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vision Restoration Therapy

NVT Eye Scanning Therapy

Eccentric Viewing Training

Sham

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Visual Perception, Vision, Ocular, Neuronal Plasticity

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Description

Group 1 - Combination Treatment

Group 2 - Combination Treatment

Group 3 - Combination Treatment

Group 4 - Combination Treatment

Group 5 - Monotherapy Treatment

Group 6 - Monotherapy Treatment

Group 7 - Monotherapy Treatment

Outcomes

Primary Outcome Measures

Dynamic Visual Field

Secondary Outcome Measures

Dynamic Visual Field

Reading Rate and Accuracy

Reading Rate

Reading Rate and Accuracy

Visual Search Accuracy and Timing

Full Information

NCT ID

NCT01214070

First Posted

September 14, 2010

Last Updated

June 14, 2017

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01214070

Brief Title

Functional Vision in TBI

Official Title

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Administrative Closure

Study Start Date

June 1, 2012 (Actual)

Primary Completion Date

November 21, 2013 (Actual)

Study Completion Date

November 21, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Visually Impaired Persons

Keywords

Visual Perception, Vision, Ocular, Neuronal Plasticity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Description

Group 1 - Combination Treatment

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

Group 2 - Combination Treatment

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Description

Group 3 - Combination Treatment

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Description

Group 4 - Combination Treatment

Arm Title

Arm 5

Arm Type

Active Comparator

Arm Description

Group 5 - Monotherapy Treatment

Arm Title

Arm 6

Arm Type

Active Comparator

Arm Description

Group 6 - Monotherapy Treatment

Arm Title

Arm 7

Arm Type

Active Comparator

Arm Description

Group 7 - Monotherapy Treatment

Intervention Type

Other

Intervention Name(s)

Vision Restoration Therapy

Intervention Description

Therapy that enhances the neuronal plasticity of the visual system

Intervention Type

Behavioral

Intervention Name(s)

NVT Eye Scanning Therapy

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Eccentric Viewing Training

Intervention Description

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

Intervention Name(s)

Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Dynamic Visual Field

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Dynamic Visual Field

Time Frame

After First Therapy / Before Second Therapy (Average time is 4.5 months)

Title

Dynamic Visual Field

Time Frame

After Second Therapy (Average Time is 9 months)

Title

Reading Rate and Accuracy

Time Frame

Baseline

Title

Reading Rate

Time Frame

After First Therapy / Before Second Therapy (average time is 4.5 months)

Title

Reading Rate and Accuracy

Time Frame

After Second Therapy (average time is 9 months)

Title

Visual Search Accuracy and Timing

Time Frame

Baseline

Title

Visual Search Accuracy and Timing

Time Frame

After First Therapy / Before Second Therapy (average time is 4.5 months)

Title

Visual Search Accuracy and Timing

Time Frame

After Second Therapy (average time is 9 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Schuchard, PhD

Organizational Affiliation

VA Palo Alto Health Care System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1290

Country

United States

12. IPD Sharing Statement

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Functional Vision in TBI

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