Music Therapy for Comatose Brain Injured Patients

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Glasgow Coma Scale score [Срок оценки: Before and after alpha-music sessions on each of the 7 study days]
• Bispectral Index [Срок оценки: Before and after alpha-music sessions on each of the 7 study days]

Вторичные конечные точки (4)

• Hospital survival or death [Срок оценки: Through study completion, an average of 1 year]
• Intensive care unit length of stay [Срок оценки: Through study completion, an average of 1 year]
• Hospital length of stay [Срок оценки: Through study completion, an average of 1 year]
• Following commands [Срок оценки: At 3 months following hospital discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• St. Elizabeth Youngstown Hospital — Youngstown
• St. Elizabeth Youngstown Hospital — Youngstown

Публикации

• 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. PMID 22042690
• 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. PMID 40602750
• Heavner MS, Gorman EF, Linn DD, Yeung SYA, Miano TA. Systematic review and meta-analysis of the correlation between bispectral index (BIS) and clinical sedation scales: Toward defining the role of BIS in critically ill patients. Pharmacotherapy. 2022 Aug;42(8):667-676. doi: 10.1002/phar.2712. Epub 2022 Jun 30. PMID 35707961
• Bilgili B, Montoya JC, Layon AJ, Berger AL, Kirchner HL, Gupta LK, Gloss DS. Utilizing bi-spectral index (BIS) for the monitoring of sedated adult ICU patients: a systematic review. Minerva Anestesiol. 2017 Mar;83(3):288 - 301. doi: 10.23736/S0375-9393.16.10886-7. Epub 2016 Jun 17. PMID 27314595
• Gu Y, Hao J, Wang J, Liang P, Peng X, Qin X, Zhang Y, He D. Effectiveness Assessment of Bispectral Index Monitoring Compared with Conventional Monitoring in General Anesthesia: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2024 Aug 7;2024:5555481. doi: 10.1155/2024/5555481. eCollection 2024. PMID 39149130
• Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3. PMID 24937564
• Rosow C, Manberg PJ. Bispectral index monitoring. Anesthesiol Clin North Am. 2001 Dec;19(4):947-66, xi. doi: 10.1016/s0889-8537(01)80018-3. PMID 11778388
• Takabatake K, Kunii N, Nakatomi H, Shimada S, Yanai K, Takasago M, Saito N. Musical Auditory Alpha Wave Neurofeedback: Validation and Cognitive Perspectives. Appl Psychophysiol Biofeedback. 2021 Dec;46(4):323-334. doi: 10.1007/s10484-021-09507-1. Epub 2021 Apr 30. PMID 33929674

Идентификаторы

NCT: NCT07544602 · 2026-TRAUMA-Dunham4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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