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

Covid19 Clinical Trial

— PREDICT-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476589
• Other study ID #: 2020P001616
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: April 7, 2022

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Consciousness Disorder
• Consciousness Disorders
• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Functional MRI
measurement of functional brain networks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fischer D, Threlkeld ZD, Bodien YG, Kirsch JE, Huang SY, Schaefer PW, Rapalino O, Hochberg LR, Rosen BR, Edlow BL. Intact Brain Network Function in an Unresponsive Patient with COVID-19. Ann Neurol. 2020 Oct;88(4):851-854. doi: 10.1002/ana.25838. Epub 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability Rating Scale score	Functional outcome measure. Maximum score of 29 represents high disability, minimum score of 0 represents no disability. Higher scores represent higher level of disability.	6 months