Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Specific biomarkers (alone or in combination) assessed 3 months after MTBI
研究概览
简要总结
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/mild traumatic brain injury (MTBI).
详细描述
This will be a prospective study of subjects with MTBI, body injury and healthy controls. Subjects who meet the study criteria will be enrolled in the study after they provide informed consent.
All subjects will be followed longitudinally at 3 and 6 months post-injury.
All subjects will have 3-4 visits:
Screening visit to determine eligibility; first study visit within 1 month of injury for those with brain or body injury (at the time of screening or within 1 month of screening for healthy controls); second study visit at 3 months post-injury (3 months after the first visit for healthy controls) and third study visit at 6 months post-injury (6 months after the first visit for healthy controls).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with MTBI: Inclusion Criteria:
- •Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
- •Have a Glasgow Coma Scale (GCS) score 13 or above
- •Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
- •Have experienced the last injury within 1 month
- •Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
- •Have sufficient cognitive capacity to provide informed consent
- •Be between 18-65 years of age and
- •Be willing to have brain MRI and a blood draw,
- •Individuals with Body Injury will meet inclusion criteria 4-
- •Instead of criteria for head injury (1-3) they would have had body injury (defined as injury below the neck (e.g., limb fractures, stab wound abdomen).
- •Age, and sex, matched normal controls: Inclusion Criteria:
- •No history of head injury or any other types of brain injury
- •Inclusion criteria 5-8
排除标准
- •History of stroke, seizures or other pre-injury neurological diseases
- •Mental Retardation
- •History of skull fracture
- •Presence of severe unstable medical disease
- •Contraindications to the MRI brain scan
- •Possibility of pregnancy
- •Presence of communication difficulties, such as moderate to severe hearing or language impairment.
结局指标
主要结局
Specific biomarkers (alone or in combination) assessed 3 months after MTBI
时间窗: 3 months after MTBI.
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders \[i.e., major depression (MD\], cognitive disorders \[i.e., executive function deficits (EFD)\], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
Specific biomarkers (alone or in combination) assessed 6 months after MTBI.
时间窗: 6 months after MTBI
This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders \[i.e., major depression (MD\], cognitive disorders \[i.e., executive function deficits (EFD)\], and functional impairment following repetitive/MTBI. This will provide pilot data for a larger study with increased sample size and more stringent panel of markers based on results obtained.
次要结局
未报告次要终点