Traumatic Brain Injury
Conditions
Keywords
observational study, traumatic brain injury, music therapy
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Mercy Health Ohio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Coma Scale score | Before and after alpha-music sessions on each of the 7 study days | The total score ranges from 3 to 15, with 15 representing a fully alert, oriented person, and 3 indicating deep coma or death. |
| Bispectral Index | Before and after alpha-music sessions on each of the 7 study days | Bispectral Index values range from 0 to 100. Lower numbers mean deeper sedation, while higher numbers indicate lighter sedation or wakefulness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital survival or death | Through study completion, an average of 1 year | Patient status (alive or dead) |
| Intensive care unit length of stay | Through study completion, an average of 1 year | Patient's length of stay in the intensive care unit |
| Hospital length of stay | Through study completion, an average of 1 year | Patient's length of stay in the hospital |
| Following commands | At 3 months following hospital discharge | This is categorized as "yes" or "no" based on whether the patient can follow commands. |
Countries
United States
Contacts
CONTACTC. Michael Dunham, MD
CONTACTGregory S Huang, MD
PRINCIPAL_INVESTIGATORC. Michael Dunham, MD
St. Elizabeth Youngstown Hospital
Outcome results
None listed