NCT04476589已完成不适用
Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Disability Rating Scale score
研究概览
简要总结
The primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from COVID-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. We aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older,
- •positive diagnosis of COVID-19,
- •diagnosis of coma, vegetative state or minimally conscious state per Glasgow Coma Scale (GCS) at time of enrollment (excluding confounders such as sedation) and
- •clinical team plan for an MRI for clinical management.
排除标准
- •A subject with any of the following MRI contraindications will not be eligible for this study:
- •electrical implants such as cardiac pacemakers or perfusion pumps
- •ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- •ferromagnetic objects such as jewelry or metal clips in clothing that cannnot be easily removed for scanning
- •pregnant volunteers
结局指标
主要结局
Disability Rating Scale score
时间窗: 6 months
Functional outcome measure. Maximum score of 29 represents high disability, minimum score of 0 represents no disability. Higher scores represent higher level of disability.
次要结局
未报告次要终点
研究者
Brian L. Edlow, M.D.
Neurocritical Care Faculty
Massachusetts General Hospital
研究点 (1)
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