Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT04712591

Conditions

Traumatic Brain Injury

Intracerebral Haemorrhage

Subarachnoid Haemorrhagic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Auditory stimuli

Study Details

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.

Conditions

Traumatic Brain Injury

Intracerebral Haemorrhage

Subarachnoid Haemorrhagic Stroke

Study ID

NCT04712591

Start date

Jun 18, 2020

Status verified date

Sep, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Auditory stimuli

Auditory stimuli (passive, active perturbations)

Primary outcome measure

  • Glasgow Outcome Scale-Extended (GOSE) Scale [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Ayham Alkhachroum, MD

(305) 243-3218axa2610@med.miami.edu

Locations

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Ayham Alkhachroum, MD

305-243-3218axa2610@med.miami.edu

Principal Investigator:

Ayham Alkhachroum, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Jan Claassen, MD

212-305-7236jc1439@cumc.columbia.edu

Angela Velazquez, MD

212-305-6071agv2113@cumc.columbia.edu

Principal Investigator:

Jan Claassen, MD

More Information

Sponsor

University of Miami

Last update posted

Sep 4, 2025

Last verified

Sep, 2025

Keywords

  • Consciousness
  • Coma
  • Recovery
  • Electroencephalogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-04.