A Pilot Study to Identify Biomarkers Associated With Chronic TBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Proteomic analysis of plasma
研究概览
简要总结
The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Chronic TBI patients:
- •Inclusion Criteria
- •Have a history of head trauma manifesting in one or more of the following:
- •Loss of consciousness
- •Post-traumatic amnesia
- •Focal neurologic deficits, seizure
- •Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
- •Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.)
排除标准
- •Inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
- •Healthy volunteers:
- •Inclusion Criteria
- •No significant medical history
- •Take no medications (other than birth control pills)
- •Fever free
- •No history of head trauma or recent injury/infection
- •No history of neurological or psychiatric disorders or alcohol or drug dependency.
- •Exclusion Criteria
- •Inability to provide informed consent
- •age/gender match not available in TBI cohort
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have,
- No significant medical history
- Take no medications (other than birth control pills)
- Fever free
- No history of head trauma or recent injury/infection
- No history of neurological or psychiatric disorders or alcohol or drug dependency.
干预措施: Blood/saliva sampling (Other)
Chronic TBI Patients - Non-penetrating
Chronic TBI patients should have a history of head trauma manifesting in one or more of the following:
- Loss of consciousness
- Post-traumatic amnesia
- Focal neurologic deficits, seizure
- Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
- Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
干预措施: Blood/saliva sampling (Other)
Chronic TBI Patients - Blast
Chronic TBI Blast injury patients should have a history of head trauma manifesting in one or more of the following:
- Loss of consciousness
- Post-traumatic amnesia
- Focal neurologic deficits, seizure
- Persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance)
- Impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) Patients will be excluded from the study if we are unable to obtain informed consent and if they are non-communicative (i.e. in a vegetative state).
干预措施: Blood/saliva sampling (Other)
结局指标
主要结局
Proteomic analysis of plasma
时间窗: average of 6 months post injury
The aim is to identify biomarkers in the blood of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups.
次要结局
- Proteomic analysis of saliva(average of 6 months post injury)
研究者
Georgene Hergenroeder
Associate Professor, Neurosurgery
The University of Texas Health Science Center, Houston