Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation.
研究概览
简要总结
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes.
详细描述
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:
- Evolve diagnostic technology & treatment
- Improve self-help strategies
- Lower cost and speed for delivery of effective strategies
The TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Fluent in English
- •Documented history of TBI or blast exposure since 2001
排除标准
- •Inability to have MRI
- •Pregnancy
- •History of TIA within last 6 months.
- •Presently involved in open litigation
研究组 & 干预措施
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: Cognitive/Neuropsychological Testing (Behavioral)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: Sleep Evaluation (Other)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: Vestibular/Ocular-Motor Testing (Other)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: Cervical (Neck) Evaluation (Other)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: HDFT MRI (Other)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: MR Spectroscopy (MRS) (Other)
History of Traumatic Brain Injury
All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial.
干预措施: MEG (Magnetoencephalography) (Other)
结局指标
主要结局
The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation.
时间窗: Up to 6 months
次要结局
- Change in the Satisfaction with Life Scale(Up to 6 months)
研究者
David Okonkwo, MD, Phd
Professor
University of Pittsburgh