Prognostication of Recovery in Early Disorders of Consciousness After COVID-19 (PREDICT-COVID)

Mass General Brigham

Status: Completed

Conditions: Consciousness Disorder; Coma; Covid19

Treatments: Diagnostic Test: Functional MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04476589

2020P001616

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

COVID-19 Disorders of Consciousness

Description:

Patients with COVID-19 and disorders of consciousness

Treatment:

Diagnostic Test: Functional MRI