Overview

This trial is active, not recruiting.

Condition ptsd
Sponsor INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborator U.S. Army Medical Research and Materiel Command
Start date October 2011
End date December 2014
Trial size 200 participants
Trial identifier NCT01625962, INTRuST-BRI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Service members who have sustained "impact-induced mTBI" or "blast-induced mTBI" (n = 100 completers)
Service members who have sustained an extracranial injury (ECI) with no evidence of TBI (n = 100 completers)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
Evaluate effect of injury type and brain structure and function
time frame: Change between Baseline and 3-months and 6-months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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) 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) 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 life events that occurred prior to most recent deployment

Additional Information

Official title Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury
Principal investigator Connie C. Duncan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium.