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NCT04712591 Clinical Trial

The EBC Recovery Study

Traumatic Brain Injury Clinical Trial

Official title:
Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04712591
Other study ID # 20191143
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2020
Est. completion date January 1, 2026

Study information
Verified date November 2023
Source University of Miami
Contact Ayham Alkhachroum, MD
Phone (305) 243-3218
Email axa2610@med.miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: For TBI Participants - TBI 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Jackson Memorial Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glasgow Outcome Scale-Extended (GOSE) Scale The GOSE is an outcome scale, range 1-8 evaluating the patients' functional outcomes - higher score indicates better recovery Up to 5 years
Secondary Coma Recovery Scale - Revised (CRS-R) The CRS-R will evaluate the patients' conscious state, range 0-23 -higher score indicates a better conscious state Up to 5 years
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