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Prognostication of Recovery in Early Disorders of Consciousness Study

NCT04692922 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-24

No results posted yet for this study

Summary

By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 6 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

Conditions

  • Disorders of Consciousness Due to Severe Brain Injury

Interventions

DIAGNOSTIC_TEST

MRI

MRI will include structural sequences (e.g., T1 weighted imaging, T2 weighted imaging, T2 FLAIR, diffusion weighted imaging with apparent diffusion coefficient, susceptibility weighted imaging, and diffusion tensor imaging). Using the structural sequences we will make note of the types of brain lesions (e.g., ischemic stroke, hemorrhage, hypoxic-ischemic brain injury), and the locations of these brain lesions. MRI will also include fMRI under three conditions: while the patient is at rest (to evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).

DIAGNOSTIC_TEST

EEG

The EEG will include resting, stimulus-based, and task-based assessments of brain function.

Sponsors & Collaborators

Principal Investigators

  • Brian L Edlow, MD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2031-06-30
Completion
2032-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692922 on ClinicalTrials.gov