Observing brain responses to music and language in unconscious patients with acute brain injuries
Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT04712591 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using auditory stimuli to assess brain activity in unconscious patients, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Miami, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.