Recovery of Consciousness Following Intracerebral Hemorrhage

NCT ID: NCT03990558

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2026-03-31

Brief 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.

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.

Conditions

Intra Cerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary ICH

Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pitié-Salpêtrière Hospital

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Jan Claassen

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Claassen, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Neurology

Locations

University of Miami and Jackson Health System (UM/JHS)

Miami, Florida, United States

Site Status: RECRUITING

Columbia University Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jan Claassen, MD

Role: CONTACT

jc1439@cumc.columbia.edu

212-305-7236

Angela Velazquez, MD

Role: CONTACT

agv2113@cumc.columbia.edu

212-305-6071

Facility Contacts

Ayham Alkhachroum, MD

Role: primary

axa2610@med.miami.edu

305-243-6175

Jan Claassen, MD

Role: primary

jc1439@cumc.columbia.edu

212-305-7236

Angela Velazquez, MD

Role: backup

agv2113@cumc.columbia.edu

212-305-6071

Other Identifiers

1R01NS106014-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS3574

Identifier Type: -

Identifier Source: org_study_id