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Structural and Functional Neuroimaging Studies of Combat Veterans

NCT01296126 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

\- Studies have shown that some people develop post-traumatic stress disorder (PTSD) after being exposed to the trauma of military combat. They may have repeated thoughts, images, and dreams of the trauma; feel detached from others; have difficulty sleeping and concentrating; or be easily startled. Some studies have also shown that after having a blow or blast to the head, some people may develop post-concussive syndrome (PCS), which may include symptoms such as headaches, difficulty concentrating, and feeling moody or irritable. Researchers are interested in using magnetic resonance imaging (MRI) to study combat veterans from Operation Iraqi Freedom or Operation Enduring Freedom in order to evaluate possible changes in the brain that may be attributed to PTSD or PCS.

Objectives:

\- To evaluate changes in brain function in recent combat veterans that may be related to post-traumatic stress disorder or post-concussive syndrome.

Eligibility:

\- Combat veterans of Operation Iraqi Freedom/Operation Enduring Freedom who are enrolled in Walter Reed Army Medical Center protocol 351030, have returned within the last 6 weeks from a deployment in Iraq or Afghanistan that lasted at least 3 months, and are able to have magnetic resonance imaging scans.

Design:

* This study involves between 1 and 4 outpatient visits to the NIH Clinical Center over the course of 1 year. The second, third, and fourth visits will occur 3, 6, and 12 months after the first visit.
* At the first visit, participants will have a baseline MRI scan, followed by a functional MRI (fMRI) scan to see what parts of the brain are used while performing simple tasks and responding to images. Participants will complete questionnaires after the scan to report on their experiences during the MRI scan.
* For the remaining three study visits, participants will have further MRI and fMRI scans and will complete additional questionnaires. Participation is complete after the 12-month study visit, or following a diagnosis of PTSD, major depression, or PCS at any time during the study.
* No treatment will be provided as part of this protocol.

Conditions

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Eric M Wassermann, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-26
Completion
2014-02-03

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296126 on ClinicalTrials.gov