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

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ClinicalTrials.gov Identifier: NCT01625962
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : March 1, 2018
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

Brief Summary:
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 or disease
PTSD

Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury
Study Start Date : October 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

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U.S. FDA Resources

Group/Cohort
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)



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. Evaluate effect of injury type and brain structure and function [ Time Frame: Change between Baseline and 3-months and 6-months ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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) (reviewed on a case by case basis)
  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) that interfere with daily functioning 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 non-combat life events that occurred prior to most recent deployment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625962


Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Virginia
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
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 Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University of the Health Sciences

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
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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:
Brain Injuries
Stress Disorders, Traumatic
Brain Injuries, Traumatic
Stress Disorders, Post-Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating