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.
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.
Who can participate
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
БГ