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

NCT01625962 | Completed DMC

• 1 other identifier: INTRuST-BRI
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD

Keywords

PTSD; mTBI; mild TBI; extracranial injury; ECI; Brain Indices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures

  Change between Baseline and 3-months and 6-months

• Evaluate effect of injury type and brain structure and function

  Change between Baseline and 3-months and 6-months

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)
• Penetrating head injury
• Medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis)
• 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) that interfere with daily functioning 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 non-combat life events that occurred prior to most recent deployment

Sponsors & Collaborators

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

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Connie C. Duncan, PhD

  Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 1, 2018

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)