Brain Injury Assessment Study at Hennepin County Medical Center
试验速览
- 阶段
- 不适用
- 发起方
- CentraCare
- 入组人数
- 774
- 主要终点
- Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking
研究概览
简要总结
The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.
详细描述
Background:
Current algorithms for assessment of the severity of brain injury include Glasgow Coma Scale score and other measures. These measures are adequate for relating acute severity but are insufficiently sensitive for subtle pathology which can result in persistent deficit. The Glasgow Coma Scale (GCS) and other measures also do not enable differentiation among types of injury. Thus patients grouped into a single GCS level entering a clinical trial may have vastly heterogeneous severity and type of injury. Because outcomes also vary accordingly, inappropriate classification undermines the integrity of a clinical trial. Improved classification of injury will enable more precise delineation of disease severity and type for patients with a traumatic brain injury (TBI) in clinical trials.
Additionally, current brain injury trials rely on outcome measures such as Glasgow Outcome Scale Extended, which capture global phenomena but fail to assess for subtle differences in outcome. Thus, many recent trials for brain injury therapeutics have failed. Sensitive outcome measures are needed to determine how well patients have recovered from brain injury in order to test therapeutics and prophylactics.
Overview of Methods:
All trauma patients that span the full spectrum ranging from non-brain injured, to CT-negative, to structurally brain injured, requiring surgery will be included in this study. A total of 1000 patients and 200 controls will be recruited over approximately 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All trauma patients that present to Hennepin County Medical Center.
排除标准
- •Age > 4 years old;
- •Major psychiatric or neurologic disorder: Active Psychotic Break, Trauma due to Suicide Attempt, Epilepsy, Multiple Sclerosis, Dementia, Guillain Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy, Significant Neurodegenerative Disorders, Muscular Dystrophy, and/or Malignant Intracranial Mass with Significant Mass Effect.
- •Developmentally Abnormal, or
- •Prisoners.
结局指标
主要结局
Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking
时间窗: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Patients will watch a video for 220 seconds as it moves clockwise around the perimeter of a monitor at about 10 seconds per side, resulting in 5 complete rotations of 40 seconds each. As the patient watches the video, their eye movements will be recorded by a camera.
Change in Proteomic Concentrations of Blood-Based Biomarkers during Recovery as Measured by Blood Draws
时间窗: Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.
Blood will be drawn for proteomic analysis at each follow-up time point. Blood will also be drawn acutely for genomic analysis.
Computed Tomography Scan
时间窗: Post-Injury Time Point of Data Collection: 1 year.
A group of patients that had an acute CT scan at admission will be selected based on presenting symptoms to undergo a CT scan at 1 year post-injury.
Change in Observable Neural Abnormalities as measured by Magnetic Resonance Imaging
时间窗: Post-Injury Time Points of Data Collection: within 1 week and at 1 year.
A group of patients will be selected based on presenting symptoms to undergo a MRI within a week of their injury and again 1 year after their injury. The sequences for these scans will include T2 Flair, susceptibility weighted imaging, diffusion weighted imaging, and diffusion tensor imaging.
次要结局
- Change in Neurological Examination during Recovery as Measured by the Neurological Outcome Scale after Traumatic Brain Injury(Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.)
- The Number of Prior Brain Injuries the Patient has Suffered as Measured with the Boston Assessment of Traumatic Brain Injury-Lifetime(Post-Injury Time Point of Data Collection: 2 weeks.)
- Change in Cognitive Functioning during Recovery as Measured by the Brief Test of Adult Cognition by Telephone(Post-Injury Time Points of Data Collection: 3 months and 1 year.)
- Change in Cognitive Function and Symptom Severity during Recovery as Measured with the Sports Concussion Assessment Tool 3 (SCAT3)(Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.)
- Change in Memory Performance during Recovery as Measured with the Galveston Orientation and Amnesia Test (GOAT)(Post-Injury Time Points of Data Collection: 3 months and 1 year.)
- Change in Quality of Life during Recovery as Measured with the Mayo-Portland Adaptability Inventory-4 (MPAI-4)(Post-Injury Time Points of Data Collection: 3 months, and 1 year.)
- Change in Global Outcome during Recovery as Measured with the Glasgow Outcome Scale-Extended (GOS-E)(Post-Injury Time Points of Data Collection: 3 months, 6 months, and 1 year.)