Study Stopped
Administrative Closure
Functional Vision in TBI
Functional Vision Consequences of Rehabilitation for TBI Vision Loss
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 4, 2010
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2013
CompletedJune 16, 2017
June 1, 2017
1.5 years
September 14, 2010
June 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dynamic Visual Field
Baseline
Secondary Outcomes (8)
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)
- +3 more secondary outcomes
Study Arms (7)
Arm 1
ACTIVE COMPARATORGroup 1 - Combination Treatment
Arm 2
ACTIVE COMPARATORGroup 2 - Combination Treatment
Arm 3
ACTIVE COMPARATORGroup 3 - Combination Treatment
Arm 4
ACTIVE COMPARATORGroup 4 - Combination Treatment
Arm 5
ACTIVE COMPARATORGroup 5 - Monotherapy Treatment
Arm 6
ACTIVE COMPARATORGroup 6 - Monotherapy Treatment
Arm 7
ACTIVE COMPARATORGroup 7 - Monotherapy Treatment
Interventions
Therapy that enhances the neuronal plasticity of the visual system
Therapy that trains eye and head scanning into the blind hemianoptic visual field
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
Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
Eligibility Criteria
You may qualify if:
- TBI (any form)
- Hemianopic Visual Field Loss
- Stable fixation
- logMAR or better Reading Acuity
- words per minute or better reading rate
You may not qualify if:
- Visual Neglect
- medical conditions that prevent sitting for 30 minutes or following instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Schuchard, PhD
VA Palo Alto Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
October 4, 2010
Study Start
June 1, 2012
Primary Completion
November 21, 2013
Study Completion
November 21, 2013
Last Updated
June 16, 2017
Record last verified: 2017-06