Observing brain responses to music and language in unconscious patients with acute brain injuries
Official title: Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury
Run by University of Miami · NCT04712591 · Data updated 2026-11-12
This study is trying to see if listening to music and language can help unconscious patients with acute brain injuries recover better by looking at their brain activity.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | June 18, 2020 |
| Main results expected | January 1, 2030 |
| Study ends | January 1, 2030 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT04712591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are unconscious due to acute brain injuries and have a Glasgow Coma Scale score of less than 8.
✕Probably not a fit
Patients under 18 years of age, pregnant women, or those who experienced cardiac arrest upon presentation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to determine whether acute brain injury patients who are clinically unconscious but show brain activation in response to auditory stimuli, such as music and language, have improved recovery outcomes. The study will utilize electroencephalogram (EEG) testing to assess brain activity in these patients. Participants will include adults aged 18 and older who are admitted to the intensive care unit with a Glasgow Coma Scale score of less than 8. The research will also involve healthy volunteers for comparative analysis.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients with severe brain injuries.
How similar studies have gone: Other studies have shown promise in using auditory stimuli to assess brain activity in unconscious patients, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Jackson Memorial Hospital
Miami, Florida, United States Recruiting -
Columbia University
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Ayham Alkhachroum, MD — University of Miami
- Study coordinator: Ayham Alkhachroum, MD
- Email: axa2610@med.miami.edu
- Phone: (305) 243-3218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.