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 : February 15, 2019
|Condition or disease|
|Consciousness Disorder Coma Brain Injuries, Traumatic|
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|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|
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 adults with no neurological, psychiatric, or medical disease.
- 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.
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
|Contact: Brian L Edlow, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Brian L Edlow, MD 617-724-6352 email@example.com|