Actively Recruiting

Age: 18Years +
All Genders
NCT03990558

Recovery of Consciousness Following Intracerebral Hemorrhage

Led by Columbia University · Updated on 2026-05-13

150

Participants Needed

2

Research Sites

615 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

P

Pitié-Salpêtrière Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objectives of the RECONFIG clinical study are to : 1. To identify the time to the first diagnosis of cognitive motor dissociation (CMD) in intracerebral hemorrhage (ICH) patients and to investigate whether these patients will clinically follow commands earlier after the hemorrhage. 2. To determine whether CMD independently predicts long term functional outcomes (6-month mRS scores) in ICH patients, and is associated with long term cognitive and quality of life outcomes. 3. To determine the EEG response to verbal commands of the motor imagery paradigm between patients with and without sensory aphasia. The overall goal is to determine predictors and the trajectory of neurological recovery.

CONDITIONS

Official Title

Recovery of Consciousness Following Intracerebral Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Diagnosis of primary intracerebral hemorrhage confirmed by Head CT and/or MRI in the frontal lobe, thalamus, or striatocapsular region
  • Unresponsive to commands within 48 hours after onset of the bleed
  • English, Spanish, or French as the primary language
Not Eligible

You will not qualify if you...

  • Major bleeding in the cortex outside of the frontal lobe, cerebellum, or brainstem deemed cause of unconsciousness
  • Other causes of intracerebral hemorrhage or different types of acute brain injury such as traumatic brain injury
  • Severe cardiorespiratory compromise or other life-threatening conditions at enrollment
  • Evidence of pre-existing aphasia or deafness
  • Unconscious before the intracerebral hemorrhage
  • Pregnancy
  • Prisoners
  • Health care proxy declines participation or chooses withdrawal of life-sustaining therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Miami and Jackson Health System (UM/JHS)

Miami, Florida, United States, 33136

Actively Recruiting

2

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

J

Jan Claassen, MD

CONTACT

A

Angela Velazquez, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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