Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study

NCT00671450 | Completed

• 1 other identifier: SHP 08-142
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Presence or absence of binocular dysfunction

  The primary outcome will be measured at a single visual screen lasting approximately one hour.

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be drawn from the patient population of the VAPAHCS PTSD Center and Clinics.

You may qualify if:

• diagnosis of PTSD
• no history of MTBI
• between 19 and 39 years of age
• a veteran

You may not qualify if:

• a history of MTBI
• over the age of 39
• an unwillingness to participate

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gregory L Goodrich, PhD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 28, 2013

Record last verified: 2009-08

Locations

US (1)