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Recruiting NCT04712591

The EBC Recovery Study

— Observational Traumatic Brain Injury Intracerebral Haemorrhage Subarachnoid Haemorrhagic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auditory stimuli.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Intracerebral Haemorrhage, Subarachnoid Haemorrhagic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury

Overview

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.

Interventions

  • Diagnostic test Auditory stimuli
    Auditory stimuli (passive, active perturbations)

Primary outcome measures

  • Glasgow Outcome Scale-Extended (GOSE) Scale [Time frame: Up to 5 years]
Secondary outcome measures (1)
  • Coma Recovery Scale - Revised (CRS-R) [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Jackson Memorial Hospital — Miami
  • Columbia University — New York

Identifiers

NCT: NCT04712591 · 20191143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗