The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure

NCT00631436 | Unknown DMC

• 2 other identifiers: PT074550CDMRP PT074550
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Study Arms (4)

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.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

National Guard Soldiers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Veterans Research and Education: lead

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples and isolated DNA and serum

MeSH Terms

Conditions

Blast Injuries; Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Barotrauma; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Scott R Sponheim, Ph.D.

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott R Sponheim, Ph.D.

CONTACT

612-467-3916; sponh001@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 21, 2011

Record last verified: 2008-02

Locations

US (1)