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 : December 16, 2020
|
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Brian L. Edlow, M.D., Massachusetts General Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
MedlinePlus related topics:
Traumatic Brain Injury
| 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 :
- 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 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 ClinicalTrials.gov identifier (NCT number): NCT03504709
Contacts
| Contact: Brian L Edlow, MD | 6177246352 | bedlow@mgh.harvard.edu | |
| Contact: Maryam Masood | 6177246352 | mmasood@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 |
| Other Study ID Numbers: |
2012P000784 |
| First Posted: | April 20, 2018 Key Record Dates |
| Last Update Posted: | December 16, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Brain Injuries Brain Injuries, Traumatic Consciousness Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Neurobehavioral Manifestations Neurologic Manifestations Neurocognitive Disorders Mental Disorders |