What this study is
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.
Study details
- Sponsor
- Mercy Health Ohio
- Conditions
- Traumatic Brain Injury
- Enrolling
- 35 people
- Starts
- 2026-05-19
- Est. completion
- 2028-04-07
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Blunt trauma
- Computed tomography confirmed intracranial hemorrhage
- Glasgow Coma Scale (GCS) score 3-8 for 48+ hours postinjury
- Mechanical ventilation
- Age ≥18 years
- Expected intensive care unit stay ≥72 hours
- Approach family on hospital day 3 for consent; start study on hospital day 3 or 4 if consent given
You can't join if
- GCS score >8 when considering candidacy
- Imminent extubation without tracheostomy
- Pregnancy or recent birth
- Hospice care
- Penetrating trauma
- Bilateral fixed pupils
- Cancer, advanced liver disease, end-stage renal disease, autoimmune disorder, prior brain disorder
- Non-survivable injury
- Other reasons in the opinion of the investigator or attending trauma physician
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openSt. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Study team
Sponsor
Mercy Health Ohio
Study ID 2026-TRAUMA-Dunham4
Principal investigator
C. Michael Dunham, MD
St. Elizabeth Youngstown Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.