Clinical trial NCT03990558: Recovery of Consciousness Following Intracerebral Hemorrhage
Official title: Recovery of Consciousness Following Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intra Cerebral Hemorrhage
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresponsive and responsive patients diagnosed with ICH.

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.

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.

Primary outcomes:
measure: Time to clinical command following
timeFrame: Hospital discharge (approximately 3 weeks)
measure: Modified Rankin Scale (mRS) Score
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life in Neurological Disorders (Neuro-QoL T-score)
timeFrame: 6 months
measure: Difference in EEG response rate to verbal commands of the motor imagery paradigm.
timeFrame: 6 months
measure: Modified Telephone Interview for Cognitive Status (TICS) score
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami and Jackson Health System (UM/JHS)
state: Florida
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Associate Professor of Neurology
name: Jan Claassen, MD
role: PRINCIPAL_INVESTIGATOR
References: