Recovery of Consciousness Following Intracerebral Hemorrhage
Recruiting now
Conditions studied: Intra Cerebral Hemorrhage
In brief
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 facts
- Study ID
- NCT03990558
- Run by
- Columbia University
- People needed
- 150
- Starts
- 2019-06-15
- Expected to finish
- 2031-03-31
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify 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.
Where it is running
- University of Miami and Jackson Health System (UM/JHS) — Miami, Florida, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.