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NCT Number: NCT04712591

The EBC Recovery Study

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Coma Consciousness Disorders Craniocerebral Trauma Hemorrhage Intracerebral Haemorrhage Intracranial Hemorrhages Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Subarachnoid Haemorrhagic Stroke Trauma, Nervous System Unconsciousness Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jackson Memorial Hospital, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory stimuli

Diagnostic Test

Auditory stimuli (passive, active perturbations)

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Ayham Alkhachroum, MD

CONTACT

[email protected]

(305) 243-3218

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jan 15, 2021
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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