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The EBC Recovery Study

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ClinicalTrials.gov Identifier: NCT04712591
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ayham Alkhachroum, University of Miami

Study Description
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Brief Summary:
The purpose of this research study to find out if clinically unconscious acute traumatic brain injury patients that show brain activation on electroencephalogram (EEG) (bedside test) have better results and wake up in the future.

Condition or disease
Traumatic Brain Injury

Study Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Traumatic Brain Injury
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Traumatic Brain Injury Patients
Traumatic brain injury (TBI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.
Healthy Volunteers
Healthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.


Outcome Measures
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Primary Outcome Measures :
  1. Glasgow Outcome Scale-Extended (GOSE) Scale [ Time Frame: Up to 5 years ]
    The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery


Secondary Outcome Measures :
  1. Coma Recovery Scale - Revised (CRS-R) [ Time Frame: Up to 5 years ]
    The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state


Eligibility Criteria
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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
Patients who present to the intensive care unit after TBI and are unconscious. Additionally, healthy volunteers will be recruited.
Criteria

Inclusion Criteria:

For TBI Participants

  • TBI adult (18 years and older) patients who are admitted to the intensive care unit
  • Unconscious with Glasgow Coma Scale (GCS) <8 on presentation and unable to follow bedside commands.
  • A negative COVID-19 test on arrival

For Healthy Volunteers:

  • 18 years and older

Exclusion Criteria:

For All Participants:

  • <18 years of age
  • Pregnant woman
  • Patients with cardiac arrest on presentation
Contacts and Locations
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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): NCT04712591


Contacts
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Contact: Ayham Alkhachroum, MD (305) 243-3218 axa2610@med.miami.edu

Locations
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United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Ayham Alkhachroum, MD    305-243-3218    axa2610@med.miami.edu   
Principal Investigator: Ayham Alkhachroum, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ayham Alkhachroum, MD University of Miami
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ayham Alkhachroum, Assistant Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT04712591    
Other Study ID Numbers: 20191143
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayham Alkhachroum, University of Miami:
Consciousness
Coma
Recovery
Electroencephalogram
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System