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Functional Vision in TBI

This study has been terminated.
(Administrative Closure)
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01214070
First received: September 14, 2010
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Brain Injuries Visually Impaired Persons Other: Vision Restoration Therapy Behavioral: NVT Eye Scanning Therapy Behavioral: Eccentric Viewing Training Behavioral: Sham Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Dynamic Visual Field [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • Dynamic Visual Field [ Time Frame: After First Therapy / Before Second Therapy (Average time is 4.5 months) ]
  • Dynamic Visual Field [ Time Frame: After Second Therapy (Average Time is 9 months) ]
  • Reading Rate and Accuracy [ Time Frame: Baseline ]
  • Reading Rate [ Time Frame: After First Therapy / Before Second Therapy (average time is 4.5 months) ]
  • Reading Rate and Accuracy [ Time Frame: After Second Therapy (average time is 9 months) ]
  • Visual Search Accuracy and Timing [ Time Frame: Baseline ]
  • Visual Search Accuracy and Timing [ Time Frame: After First Therapy / Before Second Therapy (average time is 4.5 months) ]
  • Visual Search Accuracy and Timing [ Time Frame: After Second Therapy (average time is 9 months) ]

Estimated Enrollment: 110
Actual Study Start Date: June 1, 2012
Study Completion Date: November 21, 2013
Primary Completion Date: November 21, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214070

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ron Schuchard, PhD VA Palo Alto Health Care System
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01214070     History of Changes
Other Study ID Numbers: C6687-R
Study First Received: September 14, 2010
Last Updated: June 14, 2017

Keywords provided by VA Office of Research and Development:
Visual Perception
Vision, Ocular
Neuronal Plasticity

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2017