Status:
UNKNOWN
The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure
Lead Sponsor:
Center for Veterans Research and Education
Conditions:
Blast Injuries
Traumatic Brain Injury
Eligibility:
All Genders
20-50 years
Brief Summary
Brain injury from explosive blast is a prominent feature of contemporary combat. Although protective armor and effective acute medical intervention allows soldiers to survive blast events, a growing n...
Detailed Description
Background: The clinical presentation of individuals with blast-related brain injury and post-traumatic stress reactions can be markedly similar and thus a clear description of the direct consequences...
Eligibility Criteria
Inclusion
- A high level of posttraumatic stress will be operationally defined "moderate" levels (a rating of 3 or more on a 1 to 5 scale) of the following symptoms according to Hoge et al 4: one re-experiencing symptom, three avoidance symptoms, and two hyperarousal symptoms. Staff will complete a screening interview via telephone in which the potential participant answers questions from the Blast Exposure Screen. The Blast Exposure Screen provides a comprehensive assessment of exposure to blast for the duration of deployment. Blast events will be rated for physical effects (e.g., knocked off balance, physically thrown by blast) and after effects (i.e., memory problems, headache) on the individual.
- Individuals who report memory lapses,
- Sensitivity to light or noise, headaches
- Difficulty with concentration shortly after the explosive blast and have any of the same symptoms in the past month will be invited to participate in the study.
Exclusion
- Participants will be excluded from the study if they manifest
- Current substance induced psychotic disorder or psychotic disorder due to a general medical condition than TBI
- Current or past DSM IV defined substance dependence other than alcohol, caffeine, or nicotine
- Current DSM IV substance abuse other than alcohol, caffeine, or nicotine
- A neurologic condition or DSM Axis I mental disorder prior to deployment (predeployment data from a sample of soldiers from the 1/34 BCT yielded an estimated rate of 5% of either PTSD or depression)
- Current or predeployment unstable medical condition that would likely affect brain function (e.g., clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
- Significant risk of suicidal or homicidal behavior
- Head injury from a source other than blast that resulted in loss of consciousness for more the 15 minutes, post-traumatic amnesia, skull fracture, or hospitalization. The screening interview will include questions to assess subjects with respect to the above exclusion criteria. During the telephone contact subjects will complete a screening for MRI protocols in order to exclude individuals who may have metal fragments in their bodies.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00631436
Start Date
April 1 2008
End Date
March 1 2012
Last Update
July 21 2011
Active Locations (1)
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1
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417