The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure
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|ClinicalTrials.gov Identifier: NCT00631436|
Recruitment Status : Unknown
Verified February 2008 by Minnesota Veterans Medical Research and Education Foundation.
Recruitment status was: Recruiting
First Posted : March 7, 2008
Last Update Posted : July 21, 2011
|Condition or disease|
|Blast Injuries Traumatic Brain Injury Post-Traumatic Stress Disorders|
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 of explosive blast is complicated by the emotional and cognitive sequelae of psychological trauma. The inability to clearly separate the basis of symptoms for the two conditions has hampered clinicians in prescribing effective treatments that return soldiers to maximal functioning. Measures that directly assess neural disruption may be employed to differentiate blast-related brain injury from post-traumatic psychopathology and guide effective intervention..
Objective/Hypothesis: We propose to use quantitative indices of brain electrical activity and diffusion tensor imaging (DTI) to characterize the effects of blast injury on brain function and structure. We hypothesize that Operation Iraqi Freedom (OIF) soldiers injured by explosive blast will be distinguishable from those with post-traumatic stress disorder (PTSD) on measures of brain function and structure. Specifically, blast exposure will be associated with diminished P3a amplitudes to target stimuli during sustained attention and diminished lateralized frontal potentials during recognition of previously presented words. Individuals with PTSD will exhibit normal amplitudes of P3 and lateralized frontal brain potentials. Blast affected soldiers will also have compromised white matter integrity in supracallosal, inferior frontal, and superior frontal brain regions while PTSD will not be associated with these structural abnormalities. Finally, functional brain anomalies (e.g., P3a), and frontal white matter fractional anisotropy will be associated with the adaptive functioning of soldiers.
Specific Aims: Using advanced quantitative analyses of electroencephalogram recordings we will determine the nature of functional neural anomalies related to sustained attention and memory deficits evident after injury from blast. We will determine white matter anomalies that are unique to blast injury as compared to PTSD. We will also determine which aspects of blast-related functional and structural brain abnormalities are associated with adaptive functioning in post-deployment. The long-term goals for the proposed program of research are to improve the characterization of traumatic brain injury (TBI) due to blast, describe its essential features in terms of neural function and structure to improve diagnosis, and characterize mechanisms of recovery after blast-related neural injury to facilitate the creation of interventions that target pathophysiology.
Study Design: In May of 2007 over 2650 Minnesota National Guard troops of the 1/34 BCT completed a within-theatre survey on health, exposure to blast, and traumatic events. Fifty-one percent of surveyed troops reported being close enough to an explosive blast that they felt a heat or pressure wave, had trouble hearing, or had subsequent problems with attention or memory. The proposed study will be carried out over a four-year period and include a total of 180 subjects. To determine the neural consequences of blast exposure we will compare the functional and structural brain characteristics of individuals from the 1/34 BCT who have blast injury, blast injury and PTSD, PTSD, and no blast injury or PTSD. There will be 45 demographically similar subjects in each group.
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Observational Model:||Case Control|
|Official Title:||The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
If the individuals who meet the blast exposure criteria have a PCL score above 50 and meet the Hoge et al PCL criteria, thus indicating likely PTSD, they will be invited to participate as members of the Blast Exposed + PTSD group.
Other individuals meeting the blast exposure criteria will be invited to participate in the as members of the Blast Exposed + No PTSD group if they have PCL scores below 30.
Individuals reporting that they were not exposed to explosive blast will be recruited to participate. Those not exposed to blast but with PCL scores over 50 and meeting the Hoge et al PCL criteria will be invited to participate as members of the No Blast + PTSD group.
Individuals not exposed to blast with PCL scores below 30 will be invited to participate as members of the No Blast + No PTSD group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631436
|Contact: Scott R Sponheim, Ph.D.||firstname.lastname@example.org|
|United States, Minnesota|
|Minneapolis VA Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: JoAnn Tallman 612-467-5279|
|Principal Investigator:||Scott R Sponheim, Ph.D.||Minneapolis Veterans Affairs Medical Center|