Mild Traumatic Brain Injury and Post-Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT01547819|
Recruitment Status : Withdrawn
First Posted : March 8, 2012
Last Update Posted : July 4, 2018
- 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.
- To study the relationship between PTSD and TBI.
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.
- 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.
|Condition or disease|
|Posttraumatic Stress Disorder Traumatic Brain Injury|
The primary objective of this study is to investigate the potential role of mild traumatic brain injury (mTBI) in the development of post-traumatic stress disorder (PTSD). We will characterize the central GABAergic system function in patients with PTSD after TBI (TBI-PTSD), subjects with TBI only (TBI-no PTSD), subjects with PTSD only (PTSD-no TBI ), and healthy non-TBI non-PTSD subjects (HC), using PET imaging with (11)C-Flumazenil (FMZ). Our hypothesis is that neuronal and axonal damage due to TBI results in GABAergic system dysfunction which could potentially lead to or contribute to the development of PTSD. We will also correlate the degree of (11)C-FMZ binding abnormalities with time elapsed since the original physical or psychological trauma in TBI-PTSD and PTSD-no TBI patients.
Fifty-six male and female adult subjects will be recruited: 14 subjects with PTSD following an episode of non-penetrating mTBI (TBI-PTSD), 14 subjects with mTBI but no history of PTSD (TBI-no PTSD), 14 subjects with PTSD but no history of TBI (PTSD-no TBI), and 14 healthy volunteers (HC) with no PTSD and no history of TBI. The subjects will be recruited from the Walter Reed National Military Medical Center (WRNMMC).
This is a prospective case-control study of the four subject groups mentioned above. Subjects will be stratified according to detailed psychiatric evaluation performed at WRNMMC. Subjects will not be treated with experimental therapies as part of the research study. This study will provide no direct benefit to subjects.
The main outcome measure will be (11)C-FMZ binding potential (BP) differences among these four subject groups. Other outcome measures will include Magnetic Resonance Imaging (MRI) anatomical findings and the correlation of (11)C-FMZ binding abnormalities with time elapsed since the original physical trauma in TBI-PTSD group or original psychological trauma in PTSD only group.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Imaging the GABAergic System Using 11C-flumazenil PET to Assess the Role of Mild Traumatic Brain Injury in the Development of Post Traumatic Stress Disorder|
|Study Start Date :||February 16, 2012|
|Study Completion Date :||December 18, 2013|
- 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.
- Degree of correlation between 11C-FMZ BP abnormalities and time elapsed since the original physical trauma in TBI-PTSD patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547819
|Principal Investigator:||Dima A Hammoud, M.D.||National Institutes of Health Clinical Center (CC)|