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The EBC Recovery Study

Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04712591
Enrollment
300
Registered
2021-01-15
Start date
2020-06-18
Completion date
2030-01-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Haemorrhage, Subarachnoid Haemorrhagic Stroke, Traumatic Brain Injury

Keywords

Consciousness, Coma, Recovery, Electroencephalogram

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.

Interventions

DIAGNOSTIC_TESTAuditory stimuli

Auditory stimuli (passive, active perturbations)

Sponsors

University of Miami
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glasgow Outcome Scale-Extended (GOSE) ScaleUp to 5 yearsThe GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery

Secondary

MeasureTime frameDescription
Coma Recovery Scale - Revised (CRS-R)Up to 5 yearsThe CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state

Countries

United States

Contacts

CONTACTAyham Alkhachroum, MD
axa2610@med.miami.edu(305) 243-3218
PRINCIPAL_INVESTIGATORAyham Alkhachroum, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026