The EBC Recovery Study

NCT04712591 | Recruiting

• 1 other identifier: 20191143
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Traumatic Brain Injury; Intracerebral Haemorrhage; Subarachnoid Haemorrhagic Stroke

Keywords

Consciousness; Coma; Recovery; Electroencephalogram

Outcome Measures

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

  Up to 5 years

Secondary Outcomes (1)

• Coma Recovery Scale - Revised (CRS-R)

  Up to 5 years

Study Arms (2)

Acute Brain Injury Patients

Acute brain injury (ABI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

Diagnostic Test: Auditory 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.

Diagnostic Test: Auditory stimuli

Interventions

Auditory stimuli DIAGNOSTIC_TEST

Auditory stimuli (passive, active perturbations)

Acute Brain Injury Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• years and older

You may not qualify if:

• For All Participants:
• \<18 years of age
• Pregnant woman
• Patients with cardiac arrest on presentation

Sponsors & Collaborators

• University of Miami: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Coma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ayham Alkhachroum, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayham Alkhachroum, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: June 18, 2020
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)