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Clinical Trials/NCT04476589
NCT04476589CompletedNot Applicable

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

Massachusetts General Hospital1 site in 1 country12 target enrollmentStarted: July 1, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Disability Rating Scale score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Disability Rating Scale score

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian L. Edlow, M.D.

Neurocritical Care Faculty

Massachusetts General Hospital

Study Sites (1)

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Prognostication of Recovery in Early... | Clinical Trial