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临床试验/NCT04476589
NCT04476589已完成不适用

Prognostication of Recovery in Early Disorders of Consciousness After COVID-19

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年7月1日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian L. Edlow, M.D.

Neurocritical Care Faculty

Massachusetts General Hospital

研究点 (1)

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