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Traumatic Brain InjuryNCT07544602

Music Therapy for Comatose Brain Injured Patients

An observational study of Traumatic Brain Injury, run by Mercy Health Ohio at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
How many people
35 participants
Where
2 sitesUnited States
Study dates
19 May 2026to 7 Apr 2028
How long will I take part?
7 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Trauma patients with severe traumatic brain injury admitted to St. Elizabeth Youngstown Hospital Surgical Intensive Care Unit.

Who may be able to join

  • 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

Who cannot join

  • GCS score >8 when considering candidacy
  • imminent extubation without tracheostomy
  • pregnancy or recent birth
  • hospice care
  • penetrating trauma
  • bilateral fixed pupils
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44502

Other trials in United States

About this study

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.

Read the detailed 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.

Keywords
observational study, traumatic brain injury, music therapy
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07544602
Study groupRoleWhat they receive
Matched, historical control cohortPatients with intracranial hemorrhage and blunt trauma
Alpha-music therapy cohortComatose patients with traumatic brain injury who receive alpha-music therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glasgow Coma Scale score

    The total score ranges from 3 to 15, with 15 representing a fully alert, oriented person, and 3 indicating deep coma or death.

    Measured: Before and after alpha-music sessions on each of the 7 study days

  2. Bispectral Index

    Bispectral Index values range from 0 to 100. Lower numbers mean deeper sedation, while higher numbers indicate lighter sedation or wakefulness.

    Measured: Before and after alpha-music sessions on each of the 7 study days

Secondary outcomes (4)

  1. Hospital survival or death

    Patient status (alive or dead)

    Measured: Through study completion, an average of 1 year

  2. Intensive care unit length of stay

    Patient's length of stay in the intensive care unit

    Measured: Through study completion, an average of 1 year

  3. Hospital length of stay

    Patient's length of stay in the hospital

    Measured: Through study completion, an average of 1 year

  4. Following commands

    This is categorized as "yes" or "no" based on whether the patient can follow commands.

    Measured: At 3 months following hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start19 May 2026
  3. Primary completion7 Apr 2028 (estimated)
  4. Study completion7 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07544602
Sponsor's protocol ID
2026-TRAUMA-Dunham4
Status last verified
Oct 2026
First submitted
2 Apr 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Protected Health Information will not be reused or disclosed except as required by law, for authorized oversight of the research.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33929674

  • Yang Z, Su Q, Xie J, Su H, Huang T, Han C, Zhang S, Zhang K, Xu G. Music tempo modulates emotional states as revealed through EEG insights. Sci Rep. 2025 Mar 10;15(1):8276. doi: 10.1038/s41598-025-92679-1.

    PubMed 40065030

  • Kucikiene D, Praninskiene R. The impact of music on the bioelectrical oscillations of the brain. Acta Med Litu. 2018;25(2):101-106. doi: 10.6001/actamedica.v25i2.3763.

    PubMed 30210244

  • Iwaki T, Hayashi M, Hori T. Changes in alpha band EEG activity in the frontal area after stimulation with music of different affective content. Percept Mot Skills. 1997 Apr;84(2):515-26. doi: 10.2466/pms.1997.84.2.515.

    PubMed 9106843

  • Cartocci G, Inguscio BMS, Giorgi A, Vozzi A, Leone CA, Grassia R, Di Nardo W, Di Cesare T, Fetoni AR, Freni F, Ciodaro F, Galletti F, Albera R, Canale A, Piccioni LO, Babiloni F. Music in noise recognition: An EEG study of listening effort in cochlear implant users and normal hearing controls. PLoS One. 2023 Aug 10;18(8):e0288461. doi: 10.1371/journal.pone.0288461. eCollection 2023.

    PubMed 37561758

  • Dunham CM, Ransom KJ, McAuley CE, Gruber BS, Mangalat D, Flowers LL. Severe brain injury ICU outcomes are associated with Cranial-Arterial Pressure Index and noninvasive Bispectral Index and transcranial oxygen saturation: a prospective, preliminary study. Crit Care. 2006;10(6):R159. doi: 10.1186/cc5097.

    PubMed 17105656

  • Dunham CM, Katradis DA, Williams MD. The bispectral index, a useful adjunct for the timely diagnosis of brain death in the comatose trauma patient. Am J Surg. 2009 Dec;198(6):846-51. doi: 10.1016/j.amjsurg.2009.05.032.

    PubMed 19969140

  • Alkhachroum A, Flo E, Manolovitz B, Cohan H, Shammassian B, Bass D, Aklepi G, Monexe E, Ghamasaee P, Sobczak E, Samano D, Saavedra AB, Massad N, Kottapally M, Merenda A, Cordeiro JG, Jagid J, Kanner AM, Rundek T, O'Phelan K, Claassen J, Sitt JD. Resting-State EEG Signature of Early Consciousness Recovery in Comatose Patients with Traumatic Brain Injury. Neurocrit Care. 2024 Dec;41(3):855-865. doi: 10.1007/s12028-024-02005-2. Epub 2024 May 29.

    PubMed 38811512

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by Mercy Health Ohio at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glasgow Coma Scale score (time frame: Before and after alpha-music sessions on each of the 7 study days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07544602, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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