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

Completed

• Conditions: Consciousness Disorder; Covid19; Coma
• Interventions: Diagnostic Test: Functional MRI

• Registration Number: NCT04476589
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. age 18 or older,
2. positive diagnosis of COVID-19,
3. diagnosis of coma, vegetative state or minimally conscious state per Glasgow Coma Scale (GCS) at time of enrollment (excluding confounders such as sedation) and
4. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Disorders of Consciousness	Functional MRI	Patients with COVID-19 and disorders of consciousness

Primary Outcome Measures

Name	Time	Method
Disability Rating Scale score	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States