Recruiting

Blast vs. PTSD

Sponsor:

Center for Veterans Research and Education

Code:

NCT00631436

Conditions

Blast Injuries

Traumatic Brain Injury

Post-Traumatic Stress Disorders

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

Study Details

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 number of veterans will have disability stemming from blast-related neural damage. Soldiers also return from combat with psychological disabilities caused by traumatic war events. The clinical presentation of individuals with blast-related neural damage and post-traumatic psychopathology are 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. We will use sophisticated measures of neural function and structure to characterize brain injury from explosive blasts in a sample of Operation Iraqi Freedom (OIF) National Guard soldiers who returned from deployment in the fall of 2007. Survey data gathered near the end of deployment indicated that over 50% of the brigade had been exposed to direct physical effects of explosive blasts. To fully characterize the effects of blast on the brain and differentiate them from post-traumatic stress disorder, we will contrast groups of soldiers exposed to blast and with groups experiencing post-traumatic stress disorder. This investigation will improve the characterization of blast-related traumatic brain injury, describe the essential features of the condition in terms of neural function and structure to inform diagnosis, and characterize mechanisms of recovery after blast-related neural injury to allow the creation of interventions that return soldiers to maximum levels of functioning.

Conditions

Blast Injuries

Traumatic Brain Injury

Post-Traumatic Stress Disorders

Study ID

NCT00631436

Start date

Apr, 2008

Status verified date

Feb, 2008

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

1

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.

2

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.

3

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.

4

Individuals not exposed to blast with PCL scores below 30 will be invited to participate as members of the No Blast + No PTSD group.

Central Contacts and Locations

Central contacts

Scott R Sponheim, Ph.D.

612-467-3916sponh001@umn.edu

Locations

Minneapolis VA Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

JoAnn Tallman

612-467-5279

More Information

Sponsor

Center for Veterans Research and Education

Last update posted

Jul 21, 2011

Last verified

Feb, 2008

Keywords

  • Diffusion Tensor Imaging
  • Electroencephalography
  • Blast Injury
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Veterans Research and Education on 2011-07-21.