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Recovery of Consciousness Following Intracerebral Hemorrhage

Recruitingn/aAges 18 Years - anyAllColumbia University
NCT03990558 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion 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. Exclusion Criteria: * 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.
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What it tests

  • Not listed
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Where

2 sites
University of Miami and Jackson Health System (UM/JHS)
Miami, United States
Columbia University Medical Center
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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