Recovery of Consciousness Following Intracerebral Hemorrhage

Part of paid clinical trials in Miami, Florida.

Sponsor
Columbia University
Study ID
NCT03990558
Status
Recruiting

Conditions

  • Intra Cerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 15, 2019
Status verified
May 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Primary ICH
    Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.

Primary Outcome Measure

Time to clinical command following [ Time Frame: Hospital discharge (approximately 3 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Miami and Jackson Health System (UM/JHS)MiamiFlorida33136
Ayham Alkhachroum, MD
305-243-6175
Ayham Alkhachroum, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Jan Claassen, MD
212-305-7236
Angela Velazquez, MD
212-305-6071
Jan Claassen, MD (PRINCIPAL_INVESTIGATOR)

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