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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matched, historical control cohort | Patients with intracranial hemorrhage and blunt trauma | ||
| Alpha-music therapy cohort | Comatose patients with traumatic brain injury who receive alpha-music therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Before and after alpha-music sessions on each of the 7 study days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital survival or death | Patient status (alive or dead) | Through study completion, an average of 1 year |
| Intensive care unit length of stay | Patient's length of stay in the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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Trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical Intensive Care Unit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| C. Michael Dunham, MD | Contact | 330-480-3907 | dunham.michael@sbcglobal.net | |
| Gregory S Huang, MD | Contact | 330-480-3907 | Gregory_Huang@mercy.com |
| Name | Affiliation | Role |
|---|---|---|
| C. Michael Dunham, MD | St. Elizabeth Youngstown Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22042690 | Background | Ebtehaj M, Yaqubi S, Seddighi AS, Seddighi A, Yazdi Z. Correlation between BIS and GCS in patients suffering from head injury. Ir J Med Sci. 2012 Mar;181(1):77-80. doi: 10.1007/s11845-011-0768-3. Epub 2011 Nov 1. | |
| 40602750 | Background | Mujawar AH, Bhalerao PM, Kshirsagar SJ. Correlation between bispectral index values and the Glasgow Coma Scale in traumatic brain injury patients: a prospective observational study. J Trauma Inj. 2025 Jun;38(2):97-102. doi: 10.20408/jti.2025.0026. Epub 2025 Jun 30. |
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Protected Health Information will not be reused or disclosed except as required by law, for authorized oversight of the research.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2026 | Apr 2, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2026 | Apr 2, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Through study completion, an average of 1 year |
| Hospital length of stay | Patient's length of stay in the hospital | 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. | At 3 months following hospital discharge |
| St. Elizabeth Youngstown Hospital | Youngstown | Ohio | 44502 | United States |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |