Mild Traumatic Brain Injury and Post-Traumatic Stress Disorder

NCT01547819 | Withdrawn

• 2 other identifiers: 12008212-CC-0082
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Some people who have a traumatic brain injury (TBI) recover completely. Others, however, develop post-traumatic stress disorder (PTSD), with anxiety and depression. Research suggests that levels of a brain chemical called GABA may differ in people with PTSD compared to those without PTSD. Researchers want to see if TBI can affect GABA in the brain and help develop PTSD. To look at the brain, researchers will use imaging studies with the chemical 11C-Flumazenil, which will help the scan show GABA levels in the brain. Objectives: \- To study the relationship between PTSD and TBI. Eligibility: The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).

• Individuals between 18 and 50 years of age who have PTSD and/or had a mild TBI.
• Healthy individuals between 18 and 50 years of age who have no history TBI and no history of PTSD. Design:
• Participants will be screened with a physical exam and medical history. Urine and breath samples will also be collected.
• Participants will have two imaging studies, on the same day if possible. The first will be a magnetic resonance imaging scan to look at the brain. The second will be a positron emission tomography scan with the study chemical to look at GABA pathways in the brain....

Conditions

Posttraumatic Stress Disorder; Traumatic Brain Injury

Keywords

TBI; Magnetic Resonance Imaging (MRI); PTSD; PET Imaging; 11C-Flumazenil

Outcome Measures

Primary Outcomes (1)

• The main outcome measure will be (11)C-FMZ binding potential (BP) in PTSD post mTBI as compared with nTBI without PTSD and healthy control volunteers without PTSD or TBI.

Secondary Outcomes (1)

• Degree of correlation between 11C-FMZ BP abnormalities and time elapsed since the original physical trauma in TBI-PTSD patients.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• TBI-PTSD SUBJECTS:
• Documented diagnosis of non-penetrating mTBI within the last two years.
• Diagnosis of PTSD (which is known to have occurred following the mTBI event) as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC
• Age 18-50 years of age
• TBI-no PTSD SUBJECTS:
• No history of PTSD or other major psychiatric disorders
• Mild TBI diagnosis.
• Age 18-50 years of age
• PTSD-no TBI subjects:
• No history of TBI
• PTSD diagnosis as per the diagnostic criteria followed by protocol number NNMC.2011.0035 at WRNMMC.
• Age 18-50 years of age
• Healthy Control subjects:
• No history of penetrating or non-penetrating head trauma.
• Age 18-50 years of age

You may not qualify if:

• All Subjects:
• Subjects are not eligible for participation in this research study if any of the following conditions exist:
• Subjects with history of strokes, brain tumors, seizure and other neurologic problems
• Subjects with serious medical illness such as heart disease, lung disease, kidney disease, a blood disorder like multiple myeloma, diabetes or blood vessel disease.
• Contraindication(s) to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments, morbid obesity and severe claustrophobia).
• Pregnant women or women who are breast-feeding.
• History of taking anxiolytics (namely benzodiazepines and barbiturates), anti-depressants or anti-psychotic drugs, unless abstinence for at least 4 weeks prior to the scan.
• History of taking GABAergic drugs such as gabapentin, vigabatrin, tiagabine, lamotrigine, pregabalin and others unless abstinence for at least 4 weeks prior to the scan.
• Blood alcohol concentration \>0.0 using a breathalyzer on the day of the scan.
• Evidence of heavy alcohol use based on AUDIT questionnaire (score \>8)
• Evidence of drug dependence based on the urine toxicology screen.
• History of previous radiation exposure from any source that, when combined with PET/CT scan, would exceed NIH RSC limits.
• Lifetime or current diagnosis of schizophrenia or other psychotic disorder, or bipolar disorder
• Subjects who cannot give their own consent.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Uniformed Services University of the Health Sciences: collaborator

Related Publications (3)

• Rutland-Brown W, Langlois JA, Thomas KE, Xi YL. Incidence of traumatic brain injury in the United States, 2003. J Head Trauma Rehabil. 2006 Nov-Dec;21(6):544-8. doi: 10.1097/00001199-200611000-00009.

  PMID: 17122685 BACKGROUND

• Selassie AW, Zaloshnja E, Langlois JA, Miller T, Jones P, Steiner C. Incidence of long-term disability following traumatic brain injury hospitalization, United States, 2003. J Head Trauma Rehabil. 2008 Mar-Apr;23(2):123-31. doi: 10.1097/01.HTR.0000314531.30401.39.

  PMID: 18362766 BACKGROUND

• Zaloshnja E, Miller T, Langlois JA, Selassie AW. Prevalence of long-term disability from traumatic brain injury in the civilian population of the United States, 2005. J Head Trauma Rehabil. 2008 Nov-Dec;23(6):394-400. doi: 10.1097/01.HTR.0000341435.52004.ac.

  PMID: 19033832 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Dima A Hammoud, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 8, 2012
• Study Start: February 16, 2012
• Study Completion: December 18, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-12-18