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
This trial does not accept healthy volunteersQualifiers
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 population
Unresponsive and responsive patients diagnosed with ICH.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Primary ICH
Trial outcomes
Primary outcomes
1
Time to clinical command following
To investigate whether patients will clinically follow commands earlier after the hemorrhage.
Time frame
Hospital discharge (approximately 3 weeks)2
Modified Rankin Scale (mRS) Score
A standardized interview that measures the degree of disability or dependence in the daily activities of people who have suffered causes of neurological disability. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.
Time frame
6 monthsSecondary outcomes
1
Quality of Life in Neurological Disorders (Neuro-QoL T-score)
Neuro-QoL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The T-score is the standardized score with a mean of 50 and a standard deviation of 10. For Neuro-QoL measures, higher scores equal more of the concept being measured (e.g., more Fatigue, more Lower Extremity Function - Mobility). Thus, a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Time frame
6 months2
Difference in EEG response rate to verbal commands of the motor imagery paradigm.
EEG response will be compared between patients with and without sensory aphasia.
Time frame
6 months3
Modified Telephone Interview for Cognitive Status (TICS) score
A standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The 11 test items usually take less than 10 minutes to administer and score. All examinee responses are recorded verbatim. The individual item scores are summed to obtain the TICS Total score. The TICS Total score can be interpreted by means of four qualitative impairment ranges: Unimpaired, Ambiguous, Mildly Impaired, and Moderately to Severely Impaired. TICS Total score provides a measure of global cognitive functioning and can be used to monitor changes in cognitive functioning over time. Higher score represents less cognitive impairment.
Time frame
6 monthsSponsors and contacts
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Columbia University
Lead sponsor
Pitié-Salpêtrière Hospital
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov