RECRUITING

Recovery of Consciousness Following Intracerebral Hemorrhage

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Recovery of Consciousness Following Intracerebral Hemorrhage

Quick Facts

Study Start:2019-06-15
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03990558

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older.
  2. * 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.
  3. * Unresponsive to commands within 48 hours after onset of the bleed.
  4. * English, Spanish or, French as the primary language.
  1. * Major bleeding in the cortex outside of the frontal lobe, cerebellum, or brainstem (judged as a cause for unconsciousness as per the attending neurointensivist).
  2. * Other causes of ICH or different types of acute brain injury (e.g., traumatic brain injury).
  3. * Severe cardiorespiratory compromise and similar acutely life-threatening conditions at the time of enrollment.
  4. * Evidence of pre-morbid aphasia or deafness.
  5. * Unconscious prior to ICH.
  6. * Pregnancy.
  7. * Prisoners.
  8. * Health care proxy decides against study participation or decided for withdrawal of life sustaining therapies.

Contacts and Locations

Study Contact

Jan Claassen, MD
CONTACT
212-305-7236
jc1439@cumc.columbia.edu
Angela Velazquez, MD
CONTACT
212-305-6071
agv2113@cumc.columbia.edu

Principal Investigator

Jan Claassen, MD
PRINCIPAL_INVESTIGATOR
Associate Professor of Neurology

Study Locations (Sites)

University of Miami and Jackson Health System (UM/JHS)
Miami, Florida, 33136
United States
Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Jan Claassen, MD, PRINCIPAL_INVESTIGATOR, Associate Professor of Neurology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-15
Study Completion Date2025-03

Study Record Updates

Study Start Date2019-06-15
Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

  • Intra Cerebral Hemorrhage