Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study (VDMTBI)
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Purpose
In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of binocular vision problems (such as double/blurry vision, reading difficult, etc.). These individuals are also usually diagnosed with post traumatic stress disorder (PTSD). PTSD is known to cause some vision symptoms. We wish to conduct this study on individuals with PTSD (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI. This will provide us with information useful in determining the specific cause of the visual symptoms in the MTBI population.
| Condition |
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Post-Traumatic Stress Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Visual Dysfunction in MTBI: A Comparison Group Study |
- Presence or absence of binocular dysfunction [ Time Frame: The primary outcome will be measured at a single visual screen lasting approximately one hour. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Group 1
Participants will be patients diagnosed with PTSD but with no history of TBI. Participants must be between the ages of 19 and 39. Participants must be compentent to sign a consent form and be willing ot participate in a vision screening.
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Detailed Description:
We will recruit 75 patients diagnosed with PTSD, but with no history of mild traumatic brain injury (MTBI), from the population of the VAPAHCS PTSD Center and Clinics. These volunteers will be scheduled for an eye screening developed for a concurrent project to assess visual dysfunction (accommodation/vergence insufficiency, pursuit/saccade deficits, etc.) in patients diagnosed with MTBI and seen at the Palo Alto Polytrauma Network Site clinic. The MTBI patients have unexpectedly high rates of binocular dysfunction, although their visual acuities and visual fields are normal/near normal. The MTBI diagnosis is associated with a combat blast event in some 90% of cases. Th majority of this population has also been diagnosed with PTSD. PTSD is known to cause some visual symptoms, thus it is necessary for us to determine if the visual dysfunctions in the MTBI are related to their PTSD diagnosis or not. The volunteer participants will be scheduled for an eye screening and consented prior to the screening. Inclusion criteria include diagnosis of PTSD, aged 19 to 39, and willingness to participate. Exclusion criteria is primarily history of TBI. The visual screen includes assessments of visual acuity, visual field, self-reported visual function (i.e., light sensitivity, eye fatigue, reading difficulty), and measures of accommodative function, vergence, pursuit and saccades. The data collected will be compared to the data from the ongoing study of visual dysfunction in patients diagnosed with MTBI.
Eligibility| Ages Eligible for Study: | 19 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants will be drawn from the patient population of the VAPAHCS PTSD Center and Clinics.
Inclusion Criteria:
- diagnosis of PTSD
- no history of MTBI
- between 19 and 39 years of age
- a veteran
Exclusion Criteria:
- a history of MTBI
- over the age of 39
- an unwillingness to participate
Contacts and Locations| United States, California | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304-1290 | |
| Principal Investigator: | Gregory L Goodrich, PhD | VA Palo Alto Health Care System |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00671450 History of Changes |
| Other Study ID Numbers: | SHP 08-142 |
| Study First Received: | April 30, 2008 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Vision Disorders Brain Injuries Anxiety Disorders Mental Disorders Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Eye Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013