ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03504709
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 13, 2018
Sponsor:
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

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


Group/Cohort
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

Patients:

Inclusion Criteria:

  • Traumatic Brain Injury
  • Glasgow Coma Scale (GCS) score <= 8 within 24 hours injury

Exclusion Criteria:

  • History of prior severe brain injury or dementia

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 ClinicalTrials.gov identifier (NCT number): NCT03504709


Contacts
Contact: Brian L Edlow, MD 6177246352 bedlow@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brian L Edlow, MD    617-724-6352    bedlow@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital

Publications:
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
ClinicalTrials.gov Identifier: NCT03504709     History of Changes
Other Study ID Numbers: 2012P000784
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Brain Injuries
Consciousness Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders