Structural and Functional Neuroimaging Studies of Combat Veterans

NCT01296126 | Completed

• 2 other identifiers: 11009011-N-0090
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury; PTSD

Keywords

Post Traumatic Stress Disorder (PTSD); MRI; TBI; Traumatic Brain Injury; Post Traumatic Stress Disorder; PTSD

Outcome Measures

Primary Outcomes (2)

• Images from Magnetic Resonance Imaging, including structural, functional and DTI scans

• Results from the cognitive neuroscience experiments

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Warfighters who:
• Are enrolled in WRNMMC protocol 351030.
• Have returned within the previous 8 weeks from a deployment of at least 3 months duration in Iraq or Afghanistan.

You may not qualify if:

• Warfighters who:
• Are not able to hear normal conversation.
• Do not have visual acuity correctable to 20/100 in at least one eye.
• Have had a head injury resulting in loss of consciousness for 60 minutes or more or have a current Glasgow Coma Scale \< 14.
• Have active psychotic symptoms, or active suicidal or homicidal ideation, identified on the medical history, Patient Health Questionnaire, or Clinician-Administered PTSD Scale.
• Are pregnant as shown by a pregnancy test taken during the baseline intake at WRNMMC.
• Have retained metal fragments (shrapnel), body piercings that cannot be removed, or other imbedded ferromagnetic metal resulting from trauma or surgery, which would pose a risk for MRI scanning.
• Have significant claustrophobia, including but not limited to intolerance of magnetic resonance imaging in the past, as we cannot provide sedating medications with the scans due to the potential impact of the medications on interpretation of scan results.
• Report that they regularly drink 3 or more alcoholic beverages a day.
• Report that they take illegal drugs.
• Report that they are unable to abstain from the use of alcohol, narcotics, benzodiazepines, or sleep medication for 24 hours before being scanned.
• Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 24-hour period prior to scanning. They will be excluded due to the impact of these medications on the interpretation of fMRI imaging.
• Are ill with active Acinetobacter or other clinically significant infection as identified during their military evaluation upon their return from theater.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.

  PMID: 1948051 BACKGROUND

• Belliveau JW, Rosen BR, Kantor HL, Rzedzian RR, Kennedy DN, McKinstry RC, Vevea JM, Cohen MS, Pykett IL, Brady TJ. Functional cerebral imaging by susceptibility-contrast NMR. Magn Reson Med. 1990 Jun;14(3):538-46. doi: 10.1002/mrm.1910140311.

  PMID: 2355835 BACKGROUND

• Blair KS, Smith BW, Mitchell DG, Morton J, Vythilingam M, Pessoa L, Fridberg D, Zametkin A, Sturman D, Nelson EE, Drevets WC, Pine DS, Martin A, Blair RJ. Modulation of emotion by cognition and cognition by emotion. Neuroimage. 2007 Mar;35(1):430-40. doi: 10.1016/j.neuroimage.2006.11.048. Epub 2007 Jan 18.

  PMID: 17239620 BACKGROUND

• White SF, Costanzo ME, Thornton LC, Mobley AM, Blair JR, Roy MJ. Increased cognitive control and reduced emotional interference is associated with reduced PTSD symptom severity in a trauma-exposed sample: A preliminary longitudinal study. Psychiatry Res Neuroimaging. 2018 Aug 30;278:7-12. doi: 10.1016/j.pscychresns.2018.06.006. Epub 2018 Jun 12.

  PMID: 29935441 DERIVED

• White SF, Costanzo ME, Blair JR, Roy MJ. PTSD symptom severity is associated with increased recruitment of top-down attentional control in a trauma-exposed sample. Neuroimage Clin. 2014 Nov 18;7:19-27. doi: 10.1016/j.nicl.2014.11.012. eCollection 2015.

  PMID: 25610763 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 12, 2011
• First Posted: February 15, 2011
• Study Start: January 26, 2011
• Study Completion: February 3, 2014
• Last Updated: December 16, 2019

Record last verified: 2014-02-03

Locations

US (1)