Music Therapy for Comatose Brain Injured Patients
Conditions: Traumatic Brain Injury
Sponsor: Mercy Health Ohio

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Document Date: March 24, 2026 
NCT number: To be determined 
 
Music Therapy for Comatose Brain Injured Patients 
C. Michael Dunham, Gregory S. Huang, Elisha A. Chance, Kevin Bouslough 
 
Study Purpose/Aim  
The aim of the proposed investigation 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. 
The investigators will compare cognitive function between groups at three time points: ICU discharge, hospital 
discharge, and three months after injury. 
 
 
 
Study Procedures 
Setting, Population, and Length of Study 
Trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical 
Intensive Care Unit. 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 roughly 20 
participants. 
Inclusion Criteria 
• 
blunt trauma 
• 
CT confirmed intracranial hemorrhage 
• 
Glasgow Coma Scale (GCS) 3–8 for 48+ hours 
postinjury 
• 
mechanical ventilation 
• 
age ≥18 years 
• 
expected intensive care unit (ICU) 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 >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 
 
Informed Consent 

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Eligible patients will not have the cognitive capacity to provide consent to participate. Therefore, the patient’s 
legally authorized representative (LAR), as indicated in the medical record, will be approached to provide written 
informed consent and HIPAA authorization to participate. The LAR will be approached on hospital day 3 or 4 for 
consent, after initial resuscitation and treatment. If the patient regains the ability to consent prior to the end of AMT 
course, he/she will be asked for consent. 
 
The investigators will allow approximately 3-4 days for the family to adequately understand the gravity of their 
loved one’s condition prior to approaching for consent. Informed consent will only be obtained by the listed 
qualified investigators. The treating trauma/critical care physician on duty will be available to answer any medical 
questions.  
 
Alpha-Music Therapy Sessions 
Alpha-music therapy (AMT) is to be played via headphones for 30 minutes twice each day for 7 study days (14 
sessions) unless discharged from the ICU earlier. The chosen AMT will be “Deep Alpha (440 Hz) vol. 1,” by Steven 
Halpern. AMT can be described as soothing and mildly stimulating and without lyrics. Although the AMT track is 
approximately 75 minutes, the track will be played from the beginning for 30 minutes at each AMT session. The 
volume will be maintained at a comfortable level, approximately 60 decibels. Each participant will be supplied with 
soft, over the ear headphones. A new set of headphones will be issued to each participant and will not be reused... 
The television will be turned off and other music will not be playing during the AMT session. The patient room will 
be darkened and as quiet as possible.  
 
Sessions will be coordinated with the bedside nurse to minimize interference with patient care. Patient monitoring 
before, during, and after AMT sessions include the following routine procedures: heart rate (HR), systolic blood 
pressure (BP), respiratory rate (RR), bilateral pupil size and reaction, Richmond Agitation-Sedate Scale score 
(RASS), GCS and when an intracranial pressure (ICP) monitor is in-place, ICP and cerebral perfusion pressure 
(CPP). 
 
For patient safety, AMT is initiated only when the following are present, indicating patient stability: HR 55–110, BP 
>90 and ≤170, pupils are reactive, RASS ≤+2, RR ≤24, and if an ICP is in-place, a CPP ≥60.  
 
BIS Monitoring 
BIS values are documented on each study day. BIS values are documented immediately before and after the first and 
second sessions. Even though comatose patients may exhibit no physical bodily response to sensory stimulation, 
EEG tracings have been demonstrated to show a brain electrical response. 
 
AMT session discontinuation 

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Reasons for discontinuing AMT sessions will be captured. To minimize patient harm, AMT will be discontinued 
before 30 minutes when HR >110, systolic BP >170, a pupil diameter doubles, RASS >+2, RR >24, ICP >25, or 
CPP <60. AMT sessions may be discontinued by the bedside nurse, attending trauma/critical care physician, or 
investigator for other reasons if he/she feels it is causing patient distress. Participants/LAR have the right to stop 
participating at any time. The principal investigator can end the investigation early if deemed appropriate.  
 
Other Data Collection 
In addition to the data generated during AMT sessions, the following information will be collected from the pre-
existing medical records: age, sex, Glasgow Coma Score (GCS) on admission, ICU length of stay, ventilator days, 
total hospital length of stay, comorbid conditions, hospital mortality, Injury Severity Score (ISS), Abbreviated Injury 
Score (AIS), extracranial ISS (EC-ISS), GCS at discharge, GCS at 3 months.  
 
Study Training 
Investigators will provide study education and training to attending trauma physicians, surgical residents, and 
bedside nurses in the surgical intensive care unit. The investigators will be available for oversight, monitoring, and 
clarifications.  
 
Cost 
The following items utilized for this study are not considered standard of care: 1) BIS sensors for BIS monitoring, 2) 
headphones, and 3) AMT soundtrack. Those items will be prospectively paid for by the principal investigator. 
Participants will not be charged for any items used for research purposes only. Participants will not be compensated 
for their participation.  

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AMT Session Data Form 
Study ID #______ 
 
Study Day #______ 
 
AMT Session #______ 
If receiving neuromuscular blocker:   RR, GCS and RASS are marked with an “X” 
 
Before AMT 
End of AMT 
Date and Time 
 
 
GCS 
 
 
BIS 
 
 
Heart rate 
 
 
Systolic BP 
 
 
Respiratory rate 
 
 
Right pupil size 
 
 
Right pupil reactive 
Yes                   No 
Yes                   No 
Left pupil size 
 
 
Left pupil reactive 
Yes                   No 
Yes                   No 
RASS 
 
 
ICP 
 
 
CPP 
 
 
Session Discontinued <30 minutes:   yes  /  no  
If yes, provide reason for early session discontinuation: ____________________________________ 
 
 
Statistical Analyses 
The AMT patients will be matched to a historical cohort of 1,545 patients with ICH and blunt trauma (Bon Secours 
Mercy Health, IRB number 2025-TRAUMA-Dunham). Outcome comparisons between AMT and historical control 
non-AMT patients will be used to assess efficacy. The AMT cohort will have sequential GCS and BIS values to 
assess efficacy of each AMT session. HR, BP, RR, pupils, RASS, ICP, and CPP will be used to assess risk or safety 
of each AMT session. Matching the historical control group to the intervention group will minimize intergroup bias. 
All historical control patients will have had an admission-GCS 3–8, received mechanical ventilation, had blunt 
trauma and CT intracranial hemorrhage, and an ICU stay ≥7 days. 
 
Each customized historical control patient will be matched to a single intervention patient according to age ± 5 
years, admission GCS of 3–5 or 6–8, intracranial hemorrhage Abbreviated Injury Scale score of 2–3 or 4–5, and an 
extracranial-Injury Severity Score of <6 or ≥6. 
 

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Historical control patients will be compared to intervention patients according to ventilator days, ICU days, and 
hospital days and using a t-test or a non-paired Wilcoxon test depending on the distribution. Historical control 
patients will be compared to intervention patients according to hospital mortality, no hospital discharge commands, 
and no 3-month commands using a Fisher exact or Chi-square test depending on the 2X2 expected observation 
results. 
 
A sequential GCS over a seven-day period will be determined for the historical control group. The first day for the 
historical group will be according to the hospital day for study day-1 in the matching intervention group. A mean 
pre-session GCS will be computed for each of the seven days in the intervention group. The GCS values for the 
intervention and control groups for each day will be assessed using a non-paired Wilcoxon test. A GCS comparison 
of the intervention and control groups considering all values for the seven days will be performed using a non-
parametric analysis of variance test (Kruskal-Wallis). 
 
BIS values for the intervention group will be assessed comparing all pre-session and post-session values using a 
paired Wilcoxon test. A mean pre-session and post-session BIS value will be computed for each of the three BIS 
days in the intervention group. A comparison of the mean pre-session BIS values will be assessed over the three 
days using a non-parametric analysis of variance test (Kruskal-Wallis) to determine whether BIS values are 
increasing over time. A comparison of the mean post-session BIS values will be assessed over the three days using a 
non-parametric analysis of variance test (Kruskal-Wallis) to determine whether BIS values are increasing over time. 
 
Confidentiality 
Patient anonymity will be maintained in all presentations and publications. Each participant will be assigned a study 
ID number. The identity will be known by the investigators only. The study data will be maintained in a secure excel 
file, only accessible by the investigators. All paper documentation will be stored in a locked cabinet in a badge-
controlled office. Protected Health Information (PHI) will not be reused or disclosed except as required by law, for 
authorized oversight of the research. The data will be maintained for the length required by institutional policy and 
destroyed at the earliest opportunity after publication.