Music Therapy for Comatose Brain Injured Patients (NCT07544602) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Music Therapy for Comatose Brain Injured Patients
United States35 participantsStarted 2026-04-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it realistically be an option given where my family member is right now in their recovery?
2The trial is measuring the Glasgow Coma Scale and Bispectral Index — can you explain what those two measures tell you about a patient's level of consciousness, and whether tracking them through music therapy could change how you approach treatment?
3Since this is a Phase NA trial using music therapy for comatose patients, what is currently known about whether music or auditory stimulation has any meaningful effect on arousal or recovery from traumatic brain injury?
4Are there standard-of-care approaches to stimulation or sensory input for comatose TBI patients that are already being used here, and how would participating in this trial fit alongside or instead of those?
5Given that my family member is in a coma, are there specific conditions about their stability or injury severity that would determine whether this kind of trial would even be appropriate to consider?'}
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glasgow Coma Scale score
Timeframe: Before and after alpha-music sessions on each of the 7 study days
2
Bispectral Index
Timeframe: Before and after alpha-music sessions on each of the 7 study days