The EBC Recovery Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The purpose of this research study to find out if clinically unconscious acute brain injury patients that show brain activation to music and language on electroencephalogram (EEG) (bedside test) have better outcomes and wake up in the future.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ABI 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
18 years and older
Disqualifiers
<18 years of age
Pregnant woman
Patients with cardiac arrest on presentation
Trial population
Patients who present to the intensive care unit after ABI and are unconscious. Additionally, healthy volunteers will be recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Auditory stimuli
Diagnostic testAuditory stimuli (passive, active perturbations)
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Acute Brain Injury Patients1 intervention
Group B: Healthy Volunteers1 intervention
Trial outcomes
Primary outcomes
1
Glasgow Outcome Scale-Extended (GOSE) Scale
The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery
Time frame
Up to 5 yearsSecondary outcomes
1
Coma Recovery Scale - Revised (CRS-R)
The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov