- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631436
The Effects of Explosive Blast as Compared to Post-Traumatic Stress Disorder on Brain Function and Structure
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Scott R Sponheim, Ph.D.
- Phone Number: 612-467-3916
- Email: sponh001@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Recruiting
- Minneapolis VA Medical Center
-
Contact:
- JoAnn Tallman
- Phone Number: 612-467-5279
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Scott R Sponheim, Ph.D., Minneapolis Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Trauma and Stressor Related Disorders
- Barotrauma
- Brain Injuries
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Wounds and Injuries
- Brain Injuries, Traumatic
- Blast Injuries
Other Study ID Numbers
- PT074550
- CDMRP PT074550
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States