Music Therapy for Comatose Brain Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Glasgow Coma Scale score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Glasgow Coma Scale score
时间窗: 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
时间窗: 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.
次要结局
- Hospital survival or death(Through study completion, an average of 1 year)
- Intensive care unit length of stay(Through study completion, an average of 1 year)
- Hospital length of stay(Through study completion, an average of 1 year)
- Following commands(At 3 months following hospital discharge)
研究者
C. Michael Dunham
Research Investigator
Mercy Health Ohio