Brain InjuriesPhase 4NCT01214070
Functional Vision in TBI
A Phase 4 study testing Vision Restoration Therapy, NVT Eye Scanning Therapy and Eccentric Viewing Training in people with Brain Injuries and Visually Impaired Persons, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Brain Injuries, Visually Impaired Persons
- What is being tested?
- Vision Restoration Therapy, NVT Eye Scanning Therapy and Eccentric Viewing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2012to 21 Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TBI (any form)
- Hemianopic Visual Field Loss
- Stable fixation
- 1.0 logMAR or better Reading Acuity
- 20 words per minute or better reading rate
Who cannot join
- Visual Neglect
- medical conditions that prevent sitting for 30 minutes or following instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
Official title: Functional Vision Consequences of Rehabilitation for TBI Vision Loss
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.
Read the 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.
- Conditions
- Brain Injuries, Visually Impaired Persons
- Being tested
- Vision Restoration Therapy, NVT Eye Scanning Therapy, Eccentric Viewing Training, Sham
- Keywords
- Visual Perception, Vision, Ocular, Neuronal Plasticity
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Restoration TherapyOther
Therapy that enhances the neuronal plasticity of the visual system
NVT Eye Scanning TherapyBehavioural
Therapy that trains eye and head scanning into the blind hemianoptic visual field
Eccentric Viewing TrainingBehavioural
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
ShamBehavioural
Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Group 1 - Combination Treatment Receives: Other: Vision Restoration Therapy; Behavioral: NVT Eye Scanning Therapy |
| Arm 2 | Active comparator | Group 2 - Combination Treatment Receives: Behavioral: Eccentric Viewing Training |
| Arm 3 | Active comparator | Group 3 - Combination Treatment Receives: Other: Vision Restoration Therapy; Behavioral: NVT Eye Scanning Therapy |
| Arm 4 | Active comparator | Group 4 - Combination Treatment Receives: Behavioral: Eccentric Viewing Training |
| Arm 5 | Active comparator | Group 5 - Monotherapy Treatment Receives: Other: Vision Restoration Therapy; Behavioral: Sham |
| Arm 6 | Active comparator | Group 6 - Monotherapy Treatment Receives: Behavioral: Eccentric Viewing Training; Behavioral: Sham |
| Arm 7 | Active comparator | Group 7 - Monotherapy Treatment Receives: Behavioral: NVT Eye Scanning Therapy; Behavioral: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Visual Field
Measured: Baseline
Secondary outcomes (8)
Dynamic Visual Field
Measured: After First Therapy / Before Second Therapy (Average time is 4.5 months)
Dynamic Visual Field
Measured: After Second Therapy (Average Time is 9 months)
Reading Rate and Accuracy
Measured: Baseline
Reading Rate
Measured: After First Therapy / Before Second Therapy (average time is 4.5 months)
Reading Rate and Accuracy
Measured: After Second Therapy (average time is 9 months)
Visual Search Accuracy and Timing
Measured: Baseline
Visual Search Accuracy and Timing
Measured: After First Therapy / Before Second Therapy (average time is 4.5 months)
Visual Search Accuracy and Timing
Measured: After Second Therapy (average time is 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study start1 Jun 2012
- Primary completion21 Nov 2013
- Study completion21 Nov 2013
Why it stopped: Administrative Closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ron Schuchard, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214070
- Sponsor's protocol ID
- C6687-R
- Status last verified
- Jun 2017
- First submitted
- 14 Sep 2010
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Vision Consequences of Rehabilitation for TBI Vision Loss
- ClinicalTrials.gov ID
- NCT01214070
- Acronym / sponsor ID
- C6687-R
- Conditions
- Brain Injuries, Visually Impaired Persons
- Keywords
- Visual Perception, Vision, Ocular, Neuronal Plasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Closure
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 21 Nov 2013 (actual)
- Study completion
- 21 Nov 2013 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Other: Vision Restoration Therapy, Behavioral: NVT Eye Scanning TherapyGroup 1 - Combination Treatment |
| Arm 2 | Active comparator | Behavioral: Eccentric Viewing TrainingGroup 2 - Combination Treatment |
| Arm 3 | Active comparator | Other: Vision Restoration Therapy, Behavioral: NVT Eye Scanning TherapyGroup 3 - Combination Treatment |
| Arm 4 | Active comparator | Behavioral: Eccentric Viewing TrainingGroup 4 - Combination Treatment |
| Arm 5 | Active comparator | Other: Vision Restoration Therapy, Behavioral: ShamGroup 5 - Monotherapy Treatment |
| Arm 6 | Active comparator | Behavioral: Eccentric Viewing Training, Behavioral: ShamGroup 6 - Monotherapy Treatment |
| Arm 7 | Active comparator | Behavioral: NVT Eye Scanning Therapy, Behavioral: ShamGroup 7 - Monotherapy Treatment |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TBI (any form)
- Hemianopic Visual Field Loss
- Stable fixation
- 1.0 logMAR or better Reading Acuity
- 20 words per minute or better reading rate
Key exclusion criteria (2 listed)
- Visual Neglect
- medical conditions that prevent sitting for 30 minutes or following instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision Restoration TherapyTherapy that enhances the neuronal plasticity of the visual system | Other | Arm 1, Arm 3, Arm 5 |
| NVT Eye Scanning TherapyTherapy that trains eye and head scanning into the blind hemianoptic visual field | Behavioural | Arm 1, Arm 3, Arm 7 |
| Eccentric Viewing TrainingTherapy 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 | Behavioural | Arm 2, Arm 4, Arm 6 |
| ShamTherapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit | Behavioural | Arm 5, Arm 6, Arm 7 |
Primary outcome
Dynamic Visual Field
Time frame: Baseline
8 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: Administrative Closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Schuchard, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vision Restoration Therapy, NVT Eye Scanning Therapy and Eccentric Viewing Training in people with Brain Injuries and Visually Impaired Persons, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administrative Closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Visual Field (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.