What this study is
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.
Study details
- Sponsor
- Columbia University
- Conditions
- Intra Cerebral Hemorrhage
- Enrolling
- 150 people
- Starts
- 2019-06-15
- Est. completion
- 2031-03-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Miami and Jackson Health System (UM/JHS)
Miami, Florida, United States
- Ayham Alkhachroum, MD · Contact305-243-6175axa2610@med.miami.edu
- Ayham Alkhachroum, MD · Principal investigator
RecruitingColumbia University Medical Center
New York, New York, United States
- Jan Claassen, MD · Contact212-305-7236jc1439@cumc.columbia.edu
- Angela Velazquez, MD · Contact212-305-6071agv2113@cumc.columbia.edu
- Jan Claassen, MD · Principal investigator
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAS3574
Principal investigator
Jan Claassen, MD
Associate Professor of Neurology
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.