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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04476589
Other study ID # 2020P001616
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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