Biomarkers-Driven Development of Experimental Therapeutics for Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Difference in levels BMs of neovascularization, neuroinflammation, and BM of severity of TBI and epigenetic changes in TBI group in comparison to volunteer group and trauma patients.
研究概览
简要总结
Background:
- A person who has a traumatic brain injury (TBI) -- also called concussion -- can have serious and long-lasting effects. Doctors who treat TBI need more information about how the brain changes over time in people with TBI and how well a person recovers from it. To make existing TBI treatments more effective and develop new ones, researchers want to look more closely at how TBI affects people both physically and psychologically.
Objectives:
- To collect medical information from people with recent traumatic brain injury and compare this information to that of healthy volunteers and of persons who have had injuries to other parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after surgery).
Eligibility:
3 groups of people between the ages of 18 and 70 years will be asked to take part.
- Persons who have had a traumatic brain injury (or concussion ) within the past 30 days, OR
- Persons who are healthy and have never had a traumatic brain injury, OR
- Persons who have had an injury within the past 30 days to a part of their body other than the head (such as a broken bone, orthopedic injury, surgery)
Design:
- This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit within 30 days of their injury.
- Screening: Participants will be screened with a medical history, physical examination, blood tests and electrocradiogram (ECG a routine heart test).
- The research will involve:
- Giving blood samples (no more than 75 ml each visit).
- Having tests of memory, attention, concentration, and thinking (neuropsychological testing).
- Having imaging studies of the head including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.
- Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit 2, they will not have brain MRIs or PETs.
- No treatments will be provided as part of this research protocol.
详细描述
Traumatic brain injury (TBI) is the leading cause of death and disability in people under age 45 in industrialized countries, but there is no specific treatment available for TBI. Circulating endothelial progenitor cells (EPC) are markers of vascular injury that are mobilized after signaling with cytokines, interleukins, MMP9 and other biomarkers (BM) that may be detected in blood. However, the relation of EPC and these BM to TBI severity has not been quantified. MRI measurements of lesion volume provide an objective method for TBI severity assessment and outcome prediction. Moreover, diffusion tensor imaging (DTI) is sensitive to detect TBI-related axonal injury, and PET (positron emission tomography) is useful in functional interpretation of image findings. This cross-sectional study aims to determine whether EPC and other BM are associated with MRI, DTI and PET findings, and with functional outcomes in TBI patients.
OBJECTIVES:
The primary objective of the study is to evaluate levels of EPC and other BMs participating in EPC mobilization in TBI patients in comparison to the healthy volunteers and to the non-TBI trauma controls. The second objective is to relate EPC and BM levels to TBI severity quantified by functional and radiological evaluations (MRI, DTI and PET). The third objective is to determine, if there is a relationship between the level of EPC and other BM and functional outcomes.
POPULATION:
100 male or female participants between 18 and 70 years of age will be enrolled within 30 days of a moderate TBI (classified as Glasgow Coma Scale (GCS) of 9-12) or mild TBI (GCS 13-15). If participants had post-traumatic amnesia (PTA) it must have lasted less than 7 days and any loss of consciousness (LOC) must have lasted less than 24 hours. Fifty healthy volunteers and 50 persons with non-TBI injuries (such as broken bones, orthopedic injuries or surgery) will be enrolled.
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 70 Years（Adult, Older 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
Difference in levels BMs of neovascularization, neuroinflammation, and BM of severity of TBI and epigenetic changes in TBI group in comparison to volunteer group and trauma patients.
次要结局
- Correlation of levels of the BMs of neovascularization, neuroinflammation and severity of TBI to TBI severity assessed by functional outcomes and imaging (MRI, PET) evaluations in TBI patients.