Recovery of Consciousness Following Intracerebral Hemorrhage

Intra Cerebral Hemorrhage Clinical Trial

— RECONFIG  

Official title:

Recovery of Consciousness Following Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990558
• Other study ID #: AAAS3574
• Secondary ID: 1R01NS106014-01A
• Status: Recruiting
• Start date: June 15, 2019
• Est. completion date: March 2024

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: Jan Claassen, MD
• Phone: 212-305-7236
• Email: jc1439[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Unconsciousness is common after an acute brain injury such as a brain hemorrhage, and recovery is poorly understood. This lack of knowledge is a key impediment to the development of novel strategies to improve outcomes and is one of the main reasons that prognostication of recovery of consciousness and functional outcomes is inaccurate. One-fifth of clinically unconscious patients with acute brain injury are able to follow commands using a simple, bedside EEG motor imagery test that directly measures brain activity associated with the attempt to move. This state is called cognitive motor dissociation (CMD). Pilot data indicate that CMD patients are more likely to clinically recover consciousness and have better longterm functional outcomes than non-CMD patients. To integrate these findings into clinical practice, there is a need to better understand the trajectory of CMD. This will only be possible in a tightly-controlled study with a homogenous patient cohort that is well characterized early after the injury and captures long-term outcomes. RECONFIG is a multicenter, prospective, cross-sectional observational study in patients who have a clinical diagnosis of intracerebral hemorrhage and that are unresponsive at the time of enrollment. One hundred and fifty subjects will be recruited over 4 years at 2 sites. Subjects will be assessed with behavioral measures and MRI during the acute hospitalization. Patients will be followed for 6 months to determine the functional outcome (primary outcome measure). Additionally, the investigator will study conscious intracerebral hemorrhage patients with intracerebral hemorrhage and aphasia to determine the impact of aphasia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intra Cerebral Hemorrhage

Locations

Country	Name	City	State
United States	University of Miami and Jackson Health System (UM/JHS)	Miami	Florida
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS), Pitié-Salpêtrière Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical command following	To investigate whether patients will clinically follow commands earlier after the hemorrhage.	Hospital discharge (approximately 3 weeks)
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months