Traumatic Brain InjuryNCT04712591
The EBC Recovery Study
An observational study of Traumatic Brain Injury and Intracerebral Haemorrhage, run by University of Miami at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Intracerebral Haemorrhage, Subarachnoid Haemorrhagic Stroke
- What is being tested?
- Auditory stimuli
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2020to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who present to the intensive care unit after ABI and are unconscious. Additionally, healthy volunteers will be recruited.
Who may be able to join
- 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
Who cannot join
- For All Participants:
- \<18 years of age
- Pregnant woman
- Patients with cardiac arrest on presentation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Jackson Memorial Hospital
Miami, Florida, 33136
Ayham Alkhachroum, MD, 3052433218, axa2610@med.miami.edu
Ayham Alkhachroum, MD
- Recruiting
Columbia University
New York, New York, 10032
Jan Claassen, MD, 212-305-7236, jc1439@cumc.columbia.edu
Angela Velazquez, MD, 212-305-6071, agv2113@cumc.columbia.edu
About this study
Official title: Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury
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.
- Being tested
- Auditory stimuli
- Keywords
- Consciousness, Coma, Recovery, Electroencephalogram
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory stimuliDiagnostic test
Auditory stimuli (passive, active perturbations)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Auditory stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start18 Jun 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ayham Alkhachroum, University of Miami
- Investigators
- Ayham Alkhachroum, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712591
- Sponsor's protocol ID
- 20191143
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury
- ClinicalTrials.gov ID
- NCT04712591
- Acronym / sponsor ID
- 20191143
- Keywords
- Consciousness, Coma, Recovery, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Brain Injury Patients | – | Diagnostic Test: Auditory stimuliAcute brain injury (ABI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli. |
| Healthy Volunteers | – | Diagnostic Test: Auditory stimuliHealthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the intensive care unit after ABI and are unconscious. Additionally, healthy volunteers will be recruited.
Key inclusion criteria (6 listed)
- 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
- 18 years and older
Key exclusion criteria (4 listed)
- \<18 years of age
- Pregnant woman
- Patients with cardiac arrest on presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory stimuliAuditory stimuli (passive, active perturbations) | Diagnostic test | Acute Brain Injury Patients, Healthy Volunteers |
Primary outcome
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
1 secondary outcome
Coma Recovery Scale - Revised (CRS-R)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayham Alkhachroum, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Intracerebral Haemorrhage, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayham Alkhachroum, MD ((305) 243-3218, axa2610@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale-Extended (GOSE) Scale (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.