NCT01625962

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2012-06-22
• Last updated: 2018-03-01

Locations

2 sites across 1 country: United States