Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)
This study is currently recruiting participants.
Verified April 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01625962
First received: June 20, 2012
Last updated: April 24, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
PTSD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
Primary Outcome Measures:
- Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change between Baseline and 3-months and 6-months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures [ Time Frame: Change between Baseline and 3-months and 6-months ] [ Designated as safety issue: No ]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.
- Evaluate effect of injury type and brain structure and function [ Time Frame: Change between Baseline and 3-months and 6-months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
mTBI
Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 100 completers)
|
|
ECI
Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 100 completers)
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Service members who have sustained mild TBI or extracranial injury (ECI), warranting evacuation from OEF/OIF/OND theatre to Walter Reed National Military Medical Center
Criteria
Inclusion Criteria:
- Injured while deployed or stateside
- Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using DoD criteria
- For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
- Aged 18-50
- DEERS eligible
Exclusion Criteria:
- Unable or unwilling to provide informed consent and HIPAA authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)
- Penetrating head injury
- Medical chart reveals a history of significant neurological condition(s)
- Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)
- History of major psychiatric condition(s) as revealed in the medical chart or by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)
- Record of drug or alcohol abuse or dependence in the past six months as documented in medical history review
- Medical chart or SCID reveals current or lifetime PTSD diagnosis related to life events that occurred prior to most recent deployment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625962
Contacts
| Contact: Jennifer Teng, MHS | (202) 553-9612 | jennifer.teng.ctr@usuhs.edu |
| Contact: Connie C. Duncan, PhD | (202) 782-6316 | conniecduncan@me.com |
Locations
| United States, Maryland | |
| Walter Reed National Military Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889 | |
| Contact: Jennifer Teng, MHS 202-553-9612 jennifer.teng.ctr@usuhs.edu | |
| Principal Investigator: Connie C. Duncan, PhD | |
| United States, Virginia | |
| Fort Belvoir Community Hospital | Recruiting |
| Fort Belvoir, Virginia, United States, 22060 | |
| Contact: Ileana M. Salcedo, RN, BSN 571-231-2974 ileana.m.salcedo.civ@health.mil | |
| Principal Investigator: Mark Landau, MD | |
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Connie C. Duncan, PhD | Walter Reed National Military Medical Center |
More Information
No publications provided
| Responsible Party: | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium |
| ClinicalTrials.gov Identifier: | NCT01625962 History of Changes |
| Other Study ID Numbers: | INTRuST-BRI |
| Study First Received: | June 20, 2012 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
|
PTSD mTBI mild TBI |
extracranial injury ECI Brain Indices |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Brain Injuries 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 May 16, 2013