The EBC Recovery Study

NCT ID: NCT04712591

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-18

Study Completion Date

2030-01-01

Brief Summary

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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

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Conditions

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Traumatic Brain Injury Intracerebral Haemorrhage Subarachnoid Haemorrhagic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Brain Injury Patients

Acute brain injury (ABI) patients will be recruited and studied using electroencephalogram (EEG) to monitor their brain response to auditory and visual stimuli.

Auditory stimuli

Intervention Type DIAGNOSTIC_TEST

Auditory stimuli (passive, active perturbations)

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.

Auditory stimuli

Intervention Type DIAGNOSTIC_TEST

Auditory stimuli (passive, active perturbations)

Interventions

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Auditory stimuli

Auditory stimuli (passive, active perturbations)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ayham Alkhachroum

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayham Alkhachroum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status RECRUITING

Columbia University

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ayham Alkhachroum, MD

Role: CONTACT

(305) 243-3218

Facility Contacts

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Ayham Alkhachroum, MD

Role: primary

305-243-3218

Jan Claassen, MD

Role: primary

212-305-7236

Angela Velazquez, MD

Role: backup

212-305-6071

Other Identifiers

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20191143

Identifier Type: -

Identifier Source: org_study_id

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