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

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: Jun 22, 2012
Registry last updated: Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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