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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04476589
Acronym
PREDICT-COVID
Enrollment
12
Registered
2020-07-20
Start date
2020-07-01
Completion date
2022-04-07
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma, Consciousness Disorder, Covid19

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.

Interventions

DIAGNOSTIC_TESTFunctional MRI

measurement of functional brain networks

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Disability Rating Scale score6 monthsFunctional outcome measure. Maximum score of 29 represents high disability, minimum score of 0 represents no disability. Higher scores represent higher level of disability.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026