The EBC Recovery Study

November 28, 2023 updated by: Ayham Alkhachroum, University of Miami

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Ayham Alkhachroum, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who present to the intensive care unit after TBI and are unconscious. Additionally, healthy volunteers will be recruited.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Traumatic Brain Injury Patients
Traumatic brain injury (TBI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.
Healthy Volunteers
Healthy volunteers will serve as the control group and will undergo electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Ayham Alkhachroum, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2020

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20191143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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