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REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness (RESPONSE 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03504709
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : December 16, 2020
Information provided by (Responsible Party):
Brian L. Edlow, M.D., Massachusetts General Hospital

Brief Summary:
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).

Condition or disease
Consciousness Disorder Coma Brain Injuries, Traumatic

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 5, 2022
Estimated Study Completion Date : November 1, 2027

Resource links provided by the National Library of Medicine

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.
Healthy (n=25)
Healthy adults with no neurological, psychiatric, or medical disease.

Primary Outcome Measures :
  1. Disability Rating Scale total score [ Time Frame: 6 months post injury ]
    The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening [score range 0-3], communication [score range 0-4], motor response [score range 0-5], cognitive ability for feeding [score range 0-3], cognitive ability for toileting [score range 0-3], cognitive ability for grooming [score range 0-3], level of function [score range 0-5], and employability [score range 0-3]. Subscale scores are summed to produce the total score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults admitted to the intensive care unit for acute severe traumatic brain injury


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:

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03504709

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Contact: Brian L Edlow, MD 6177246352
Contact: Maryam Masood 6177246352

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brian L Edlow, MD    617-724-6352   
Sponsors and Collaborators
Massachusetts General Hospital
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Responsible Party: 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), Massachusetts General Hospital Identifier: NCT03504709    
Other Study ID Numbers: 2012P000784
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Consciousness Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders