Recovery of Consciousness Following Intracerebral Hemorrhage

Description

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

Intra Cerebral Hemorrhage

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Study Overview

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Study Details

Study overview

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.

Recovery of Consciousness Following Intracerebral Hemorrhage

Recovery of Consciousness Following Intracerebral Hemorrhage

Condition
Intra Cerebral Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami and Jackson Health System (UM/JHS), Miami, Florida, United States, 33136

New York

Columbia University Medical Center, New York, New York, United States, 10032

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years or older.
  • * Diagnosis of primary ICH (i.e., related to hypertension or anticoagulants) on 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.
  • * Major bleeding in the cortex outside of the frontal lobe, cerebellum, or brainstem (judged as a cause for unconsciousness as per the attending neurointensivist).
  • * Other causes of ICH or different types of acute brain injury (e.g., traumatic brain injury).
  • * Severe cardiorespiratory compromise and similar acutely life-threatening conditions at the time of enrollment.
  • * Evidence of pre-morbid aphasia or deafness.
  • * Unconscious prior to ICH.
  • * Pregnancy.
  • * Prisoners.
  • * Health care proxy decides against study participation or decided for withdrawal of life sustaining therapies.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Jan Claassen, MD, PRINCIPAL_INVESTIGATOR, Associate Professor of Neurology

Study Record Dates

2025-03