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CompletedNCT04476589PREDICT-COVIDUpdated Apr 4, 2023

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

An observational study in Covid19, Coma and Consciousness Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Covid19
  • Coma
  • Consciousness Disorder
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 12 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Survivors of severe COVID-19 who have disorders of consciousness

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID-19 Disorders of Consciousness

    Patients with COVID-19 and disorders of consciousness

    Diagnostic Test: Functional MRI

Interventions

  • Diagnostic testFunctional MRI

    measurement of functional brain networks

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Publications

  • 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 2020 Aug 6. PubMed 32613682 ↗
  • Fischer D, Snider SB, Barra ME, Sanders WR, Rapalino O, Schaefer P, Foulkes AS, Bodien YG, Edlow BL. Disorders of Consciousness Associated With COVID-19: A Prospective Multimodal Study of Recovery and Brain Connectivity. Neurology. 2022 Jan 18;98(3):e315-e325. doi: 10.1212/WNL.0000000000013067. Epub 2021 Dec 3. PubMed 34862317 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04476589
Lead sponsor
Massachusetts General Hospital
Responsible party
Brian L. Edlow, M.D. (Neurocritical Care Faculty, Massachusetts General Hospital) — Principal investigator
First posted
Jul 20, 2020
Start date
Jul 1, 2020
Primary completion
Apr 7, 2022
Completion
Apr 7, 2022
Last update
Apr 4, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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