The EBC Recovery Study

Recruiting

• Conditions: Traumatic Brain Injury; Intracerebral Haemorrhage; Subarachnoid Haemorrhagic Stroke
• Interventions: Diagnostic Test: Auditory stimuli

• Registration Number: NCT04712591
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research study to find out if clinically unconscious acute brain injury patients that show brain activation to music and language on electroencephalogram (EEG) (bedside test) have better outcomes and wake up in the future.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-18
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For ABI Participants

• ABI adult (18 years and older) patients who are admitted to the intensive care unit
• Unconscious with Glasgow Coma Scale (GCS) <8 on presentation and unable to follow bedside commands.
• A negative COVID-19 test on arrival

For Healthy Volunteers:

• 18 years and older

Exclusion Criteria

For All Participants:

• <18 years of age
• Pregnant woman
• Patients with cardiac arrest on presentation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Brain Injury Patients	Auditory stimuli	Acute brain injury (ABI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.
Healthy Volunteers	Auditory stimuli	Healthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale-Extended (GOSE) Scale	Up to 5 years	The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery

Secondary Outcome Measures

Name	Time	Method
Coma Recovery Scale - Revised (CRS-R)	Up to 5 years	The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States