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RecruitingNCT04712591Updated Sep 8, 2026

The EBC Recovery Study

An observational study in Traumatic Brain Injury, Intracerebral Haemorrhage and Subarachnoid Haemorrhagic Stroke, sponsored by University of Miami. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Miami · Observational

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Intracerebral Haemorrhage
  • Subarachnoid Haemorrhagic Stroke

Keywords

  • Consciousness
  • Coma
  • Recovery
  • Electroencephalogram
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's planned enrollment of 300 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

For All Participants:

  • \<18 years of age
  • Pregnant woman
  • Patients with cardiac arrest on presentation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testAuditory stimuli

    Auditory stimuli (passive, active perturbations)

06

What researchers measure

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 years

Secondary 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 years

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04712591
Responsible party
Ayham Alkhachroum (Associate Professor of Neurology, University of Miami) — Principal investigator
First posted
Jan 15, 2021
Start date
Jun 18, 2020
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Sep 8, 2026

Study contacts

Ayham Alkhachroum, MD
Contact
axa2610@med.miami.edu
(305) 243-3218
Ayham Alkhachroum, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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