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NCT Number: NCT07544602

Music Therapy for Comatose Brain Injured Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Elizabeth Youngstown Hospital, Youngstown, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glasgow Coma Scale score

    Time frame: 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.

  2. Bispectral Index

    Time frame: 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.

Secondary outcomes

  1. Hospital survival or death

    Time frame: Through study completion, an average of 1 year

    Patient status (alive or dead)

  2. Intensive care unit length of stay

    Time frame: Through study completion, an average of 1 year

    Patient's length of stay in the intensive care unit

  3. Hospital length of stay

    Time frame: Through study completion, an average of 1 year

    Patient's length of stay in the hospital

  4. Following commands

    Time frame: At 3 months following hospital discharge

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

Study contacts

Contact information is provided by the study sponsor or research team.

C. Michael Dunham, MD

CONTACT

[email protected]

330-480-3907

Gregory S Huang, MD

CONTACT

[email protected]

330-480-3907

Sponsors and collaborators

Lead sponsor

Mercy Health Ohio

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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