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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- 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.
研究概览
简要总结
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....
详细描述
Objective
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.
Study Population
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).
Design
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
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.
次要结局
- Degree of correlation between 11C-FMZ BP abnormalities and time elapsed since the original physical trauma in TBI-PTSD patients.