An observational study in Traumatic Brain Injury, sponsored by Mercy Health Ohio. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Mercy Health Ohio · Observational
The goal of this single-arm observational study is to determine whether alpha music therapy, initiated early in the recovery period, can improve cognitive function for severe traumatic brain injury patients when compared to historic controls. Participants will listen to selected music through headphones. The investigators will compare cognitive function between groups at three time points: ICU discharge, hospital discharge, and three months after injury.
This single-arm observational study will include trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical Intensive Care Unit (ICU). Individual participation will last for 7 days (14 sessions) or until ICU discharge, whichever occurs first. The investigation is expected to last approximately 2 years (2026-2028) to accrue approximately 20 participants. Alpha-music therapy (AMT) will be played via headphones for 30 minutes twice each day for 7 study days (14 sessions) unless discharged from the ICU earlier. Patient monitoring will be performed before, during, and after AMT sessions.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 35 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Mercy Health Ohio is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical Intensive Care Unit.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with intracranial hemorrhage and blunt trauma
Comatose patients with traumatic brain injury who receive alpha-music therapy
Glasgow Coma Scale score
The total score ranges from 3 to 15, with 15 representing a fully alert, oriented person, and 3 indicating deep coma or death.
Time frame: Before and after alpha-music sessions on each of the 7 study days
Bispectral Index
Bispectral Index values range from 0 to 100. Lower numbers mean deeper sedation, while higher numbers indicate lighter sedation or wakefulness.
Time frame: Before and after alpha-music sessions on each of the 7 study days
Hospital survival or death
Patient status (alive or dead)
Time frame: Through study completion, an average of 1 year
Intensive care unit length of stay
Patient's length of stay in the intensive care unit
Time frame: Through study completion, an average of 1 year
Hospital length of stay
Patient's length of stay in the hospital
Time frame: Through study completion, an average of 1 year
Following commands
This is categorized as "yes" or "no" based on whether the patient can follow commands.
Time frame: At 3 months following hospital discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Protected Health Information will not be reused or disclosed except as required by law, for authorized oversight of the research.
Started May 2026 (actual). Primary completion is estimated for Apr 2028, 22 months after the start.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 22 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → May 2026, on Oct 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Mercy Health Ohio