The EBC Recovery Study

University of Miami300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Traumatic Brain Injury Intracerebral Haemorrhage Subarachnoid Haemorrhagic Stroke

Interventions

Auditory stimuliDIAGNOSTIC_TEST

Auditory stimuli (passive, active perturbations)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For ABI Participants * 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 For Healthy Volunteers: * 18 years and older Exclusion Criteria: For All Participants: * \<18 years of age * Pregnant woman * Patients with cardiac arrest on presentation

Locations (2)

Jackson Memorial Hospital

Miami, Florida, United States

RECRUITING

Columbia University

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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 years

Secondary Outcomes

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 years

Central Contacts

Ayham Alkhachroum, MD

CONTACT

(305) 243-3218 axa2610@med.miami.edu

Data from ClinicalTrials.gov

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