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

Status:	Completed
Conditions:	Hospital, Neurology, Psychiatric
Therapuetic Areas:	Neurology, Psychiatry / Psychology, Other
Healthy:	No
Age Range:	18 - 50
Updated:	4/17/2018
Start Date:	October 2011
End Date:	March 2016

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.

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

We found this trial at

sites

Walter Reed National Military Medical Center

8901 Rockville Pike
Bethesda, Maryland 20889

(301) 295-4000