Music Therapy for Comatose Brain Injured Patients

NCT07544602 | Not Yet Recruiting DMC

• 1 other identifier: 2026-TRAUMA-Dunham4
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

observational study; traumatic brain injury; music therapy

Outcome Measures

Primary Outcomes (2)

• 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.

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

• Bispectral Index

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

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

Secondary Outcomes (4)

• Hospital survival or death

  Through study completion, an average of 1 year

• Intensive care unit length of stay

  Through study completion, an average of 1 year

• Hospital length of stay

  Through study completion, an average of 1 year

• Following commands

  At 3 months following hospital discharge

Study Arms (2)

Matched, historical control cohort

Patients with intracranial hemorrhage and blunt trauma

Alpha-music therapy cohort

Comatose patients with traumatic brain injury who receive alpha-music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Health Ohio: lead

Study Sites (2)

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

Location

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44502, United States

Location

Related Publications (56)

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MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• C. Michael Dunham, MD

  St. Elizabeth Youngstown Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C. Michael Dunham, MD

CONTACT

330-480-3907; dunham.michael@sbcglobal.net

Gregory S Huang, MD

CONTACT

330-480-3907; Gregory_Huang@mercy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 22, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 7, 2028
• Study Completion (Estimated): April 7, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)