Recovery of Consciousness Following Intracerebral Hemorrhage (RECONFIG)

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 Overview

• Status: Recruiting
• Conditions: Intra Cerebral Hemorrhage

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Jan Claassen, MD; Phone Number: 212-305-7236; Email: jc1439@cumc.columbia.edu
• Study Contact Backup: Name: Angela Velazquez, MD; Phone Number: 212-305-6071; Email: agv2113@cumc.columbia.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami and Jackson Health System (UM/JHS)
      • Principal Investigator: Ayham Alkhachroum, MD
      • Contact: Ayham Alkhachroum, MD; Phone Number: 305-243-6175; Email: axa2610@med.miami.edu
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Jan Claassen, MD; Phone Number: 212-305-7236; Email: jc1439@cumc.columbia.edu
      • Contact: Angela Velazquez, MD; Phone Number: 212-305-6071; Email: agv2113@cumc.columbia.edu
      • Principal Investigator: Jan Claassen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Unresponsive and responsive patients diagnosed with ICH.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary ICH; Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical command following	To investigate whether patients will clinically follow commands earlier after the hemorrhage.	Hospital discharge (approximately 3 weeks)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Pitié-Salpêtrière Hospital
• Investigators: Principal Investigator: Jan Claassen, MD, Associate Professor of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: AAAS3574; 1R01NS106014-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No