Prognostication of Recovery in Early Disorders of Consciousness Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Detection of technologic covert consciousness
研究概览
简要总结
The goal of this study is to determine the extent to which neuroimaging metrics (e.g., functional MRI) are associated with the current level of consciousness, and future consciousness recovery, in patients with disorders of consciousness resulting from acute brain injury. The main questions this study aims to answer are:
How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with current level of consciousness? How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with future recovery of consciousness? How does noxious stimulation affect the detection of covert consciousness and functional brain network connectivity?
详细描述
Patients with disorders of consciousness (lacking overt signs of consciousness such as command-following) due to acute brain injury will be identified and enrolled via the Recovery of Consciousness Via Evidence-Based Medicine and Research (RECOVER) Program. Patients in the study will undergo a detailed behavioral consciousness assessment (with the Coma Recovery Scale - Revised [CRS-R]), conducted by specially trained personnel, as well as a task-based functional MRI with auditory stimulation (motor commands) to assess for technologic covert consciousness (the willful modulation of brain activity to command) and functional brain network connectivity. For a subset of patients, the functional MRI will be performed with and without noxious stimulation, during the same scanning session. Patients will undergo repeat behavioral evaluations at hospital discharge, and 3 and 6 months after, to assess for overt consciousness recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Inclusion Criteria:
- •Acute brain injury (including, but not limited to ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, or encephalitis)
- •Inability to follow commands due to a disorder of consciousness (comatose, vegetative, or minimally conscious state) caused by the underlying brain injury
- •Age 18 or greater
- •Enrolled within 28 days of brain injury
排除标准
- •Imminent death (as indicated, for example, by planned transition to palliative measures, brain death testing, or severe medical instability)
- •MRI contraindications would exclude patients from imaging component of study
- •For healthy controls:
- •Exclusion Criteria:
- •MRI contraindications
- •History of brain injury to neurological disease
- •History of diabetes, high blood pressure, kidney disease
研究组 & 干预措施
Single arm
Patients and healthy controls will undergo functional MRI, which may include auditory and noxious stimulation.
干预措施: Functional MRI (fMRI) (Diagnostic Test)
结局指标
主要结局
Detection of technologic covert consciousness
时间窗: Baseline, during hospitalization (estimated approximately 1 month from brain injury)
Brain activity during the delivery of commands, as compared to brain activity during rest, will be measured during the functional MRI scan. Brain activity that is significantly more associated with commands and that occurs in the premotor cortex or supplementary motor area will be interpreted as evidence of technologic covert consciousness.
Functional network connectivity
时间窗: Baseline, during hospitalization (estimated approximately 1 month from brain injury)
Functional connectivity of brain networks will be measured during a resting state functional MRI sequence without noxious stimulation. Another sequence may be obtained during noxious stimulation.
Detection of behavioral covert consciousness
时间窗: Baseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI
The Coma Recovery Scale - Revised (CRS-R) will be used to assess the presence of behavioral covert consciousness, defined as the minimally conscious state minus (non-language based, but purposeful, behaviors), or the minimally conscious state plus (command-following, intelligible verbalization, and intentional communication). Higher scores (maximum 23) reflect higher levels of consciousness than lower scores (minimum 0).
Overt consciousness recovery based on Disability Rating Scale
时间窗: Through study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge
Overt consciousness, defined as command-following as measured with the Disability Rating Scale, will be evaluated at hospital discharge, and 3 and 6 months afterwards.
次要结局
未报告次要终点
研究者
David Fischer
Principal Investigator
University of Pennsylvania