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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTBI | Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 74 completers) | ||
| ECI | Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 32 completers) |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS) | To evaluate the associations between (1) baseline indices of brain structure and function and (2) course of PTSD symptoms in service members with TBI and ECI over the 6-month follow-up period. | Change between Baseline and 3-months and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures | To evaluate the associations between (1) the selected baseline indices of brain structure and function, and (2) course of post-concussive symptoms, self-reported health status, including headache, overall emotional distress, and quality of life over the 6-month follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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Service members who have sustained mild TBI or extracranial injury (ECI), and have received care at Walter Reed National Military Medical Center or Fort Belvoir Community Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Connie C. Duncan, PhD | Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States | ||
| Fort Belvoir Community Hospital |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Change between Baseline and 3-months and 6-months |
| Evaluate effect of injury type and brain structure and function | To evaluate the effect of type of injury (impact TBI vs. blast TBI vs. ECI) on selected indices of brain structure and function at baseline and at the 6-month follow-up period. | Change between Baseline and 3-months and 6-months |
| Fort Belvoir |
| Virginia |
| 22060 |
| United States |