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

Massachusetts General Hospital1 site in 1 country12 target enrollmentJuly 1, 2020

ConditionsCovid19 Coma Consciousness Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Covid19
Sponsor: Massachusetts General Hospital
Enrollment: 12
Locations: 1
Primary Endpoint: Disability Rating Scale score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

April 7, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Brian L. Edlow, M.D.

Neurocritical Care Faculty

Massachusetts General Hospital

Eligibility Criteria

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.