Trial record 5 of 6 for:    Open Studies | "Barotrauma"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Minnesota Veterans Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier:
NCT00631436
First received: February 28, 2008
Last updated: July 20, 2011
Last verified: February 2008
  Purpose

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.


Condition
Blast Injuries
Traumatic Brain Injury
Post-Traumatic Stress Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure

Resource links provided by NLM:


Further study details as provided by Minnesota Veterans Research Institute:

Biospecimen Retention:   Samples With DNA

Whole blood samples and isolated DNA and serum


Estimated Enrollment: 180
Study Start Date: April 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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 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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

National Guard Soldiers

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631436

Contacts
Contact: Scott R Sponheim, Ph.D. 612-467-3916 sponh001@umn.edu

Locations
United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: JoAnn Tallman    612-467-5279      
Sponsors and Collaborators
Minnesota Veterans Research Institute
Investigators
Principal Investigator: Scott R Sponheim, Ph.D. Minneapolis Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: Scott Sponheim, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier: NCT00631436     History of Changes
Other Study ID Numbers: PT074550, CDMRP PT074550
Study First Received: February 28, 2008
Last Updated: July 20, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Minnesota Veterans Research Institute:
Diffusion Tensor Imaging
Electroencephalography
Blast Injury
Traumatic Brain Injury

Additional relevant MeSH terms:
Barotrauma
Disease
Stress Disorders, Traumatic
Brain Injuries
Stress Disorders, Post-Traumatic
Blast Injuries
Pathologic Processes
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014