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

Completed

• Conditions: PTSD

• Registration Number: NCT01625962
• Lead Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Primary Completion: 2015-03
• Status Verified: 2015-08
• Study Completion: 2016-03
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS)	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 Outcome Measures

Name	Time	Method
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	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	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.

Trial Locations

Locations (2)

Fort Belvoir Community Hospital; 🇺🇸 Fort Belvoir, Virginia, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States