Recovery of Consciousness Following Intracerebral Hemorrhage
ConditionIntra Cerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 1 trial groupSponsors and collaborators
Columbia University
Lead sponsor
Pitié-Salpêtrière Hospital
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov