Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
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: October 25, 2013
Last verified: October 2013
  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: June 2014
Estimated Primary Completion Date: June 2014 (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:

  1. Injured while deployed or stateside
  2. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
  3. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
  4. Aged 18-50
  5. Defense Enrollment Eligibility Reporting System (DEERS) eligible

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)
  2. Penetrating head injury
  3. Medical chart reveals a history of significant neurological condition(s)
  4. Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)
  5. 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)
  6. Record of drug or alcohol abuse or dependence in the past six months as documented in medical history review
  7. Medical chart or SCID reveals current or lifetime PTSD diagnosis related to life events that occurred prior to most recent deployment
  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: 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: Jennifer Teng, MHS    202-553-9612    jennifer.teng.ctr@usuhs.edu   
Principal Investigator: Heechin Chae, 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: October 25, 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
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 29, 2014