Functional Vision in TBI

Brain Injuries Clinical Trial

Official title:

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01214070
• Other study ID #: C6687-R
• Status: Terminated
• Phase: Phase 4
• First received: September 14, 2010
• Last updated: June 14, 2017
• Start date: June 1, 2012
• Est. completion date: November 21, 2013

Study information

• Verified date: June 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: November 21, 2013
• Est. primary completion date: November 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Visually Impaired Persons

Intervention

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

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Visual Field		Baseline
Secondary	Dynamic Visual Field		After First Therapy / Before Second Therapy (Average time is 4.5 months)
Secondary	Dynamic Visual Field		After Second Therapy (Average Time is 9 months)
Secondary	Reading Rate and Accuracy		Baseline
Secondary	Reading Rate		After First Therapy / Before Second Therapy (average time is 4.5 months)
Secondary	Reading Rate and Accuracy		After Second Therapy (average time is 9 months)
Secondary	Visual Search Accuracy and Timing		Baseline
Secondary	Visual Search Accuracy and Timing		After First Therapy / Before Second Therapy (average time is 4.5 months)
Secondary	Visual Search Accuracy and Timing		After Second Therapy (average time is 9 months)