REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-05

Study Completion Date

2023-10-23

Brief Summary

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The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).

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Detailed Description

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Conditions

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Consciousness Disorder Coma Brain Injuries, Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient (n=50)

Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury.

No interventions assigned to this group

Healthy (n=25)

Healthy adults with no neurological, psychiatric, or medical disease.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Traumatic Brain Injury
* Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
* Clinical evidence of disorder of consciousness defined as coma, VS, or MCS

Exclusion Criteria

* History of prior severe brain injury or dementia
* Emergence from MCS at time of initial CRS-R assessment

Healthy Subjects:

History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Brian L. Edlow, M.D.

Neurocritical Care Faculty, Massachusetts General Hospital, Associate Director, Center for Neurotechnology and Neurorecovery (CNTR) Director, Laboratory for NeuroImaging of Coma and Consciousness (NICC)

Responsibility Role PRINCIPAL_INVESTIGATOR