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

Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: PTSD

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Virginia
    • Fort Belvoir, Virginia, United States, 22060
      • Fort Belvoir Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborators: U.S. Army Medical Research and Development 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

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 22, 2012

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: PTSD; mTBI; mild TBI; extracranial injury; ECI; Brain Indices
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Brain Injuries; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: INTRuST-BRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES