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

NCT ID: NCT01625962

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mTBI

Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 74 completers)

No interventions assigned to this group

ECI

Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 32 completers)

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Connie C. Duncan, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Countries

United States

Other Identifiers

INTRuST-BRI

Identifier Type: -

Identifier Source: org_study_id