ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)
NCT07739264
Brain Diseases, Brain Injuries
Dhaka, Bangladesh
View Trial DetailsNCT Number: NCT07544602
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
St. Elizabeth Youngstown Hospital, Youngstown, Ohio, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through study completion, an average of 1 year
Patient status (alive or dead)
Time frame: Through study completion, an average of 1 year
Patient's length of stay in the intensive care unit
Time frame: Through study completion, an average of 1 year
Patient's length of stay in the hospital
Time frame: At 3 months following hospital discharge
This is categorized as "yes" or "no" based on whether the patient can follow commands.
Contact information is provided by the study sponsor or research team.
C. Michael Dunham, MD
CONTACT
Gregory S Huang, MD
CONTACT
Mercy Health Ohio
Other
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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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