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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS106014-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Pitié-Salpêtrière Hospital | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The objectives of the RECONFIG clinical study are to :
The overall goal is to determine predictors and the trajectory of neurological recovery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary ICH | Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Unresponsive and responsive patients diagnosed with ICH.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Claassen, MD | Contact | 212-305-7236 | jc1439@cumc.columbia.edu | |
| Angela Velazquez, MD | Contact | 212-305-6071 | agv2113@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jan Claassen, MD | Associate Professor of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami and Jackson Health System (UM/JHS) | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39443437 | Derived | Heinonen GA, Carmona JC, Grobois L, Kruger LS, Velazquez A, Vrosgou A, Kansara VB, Shen Q, Egawa S, Cespedes L, Yazdi M, Bass D, Saavedra AB, Samano D, Ghoshal S, Roh D, Agarwal S, Park S, Alkhachroum A, Dugdale L, Claassen J. A Survey of Surrogates and Health Care Professionals Indicates Support of Cognitive Motor Dissociation-Assisted Prognostication. Neurocrit Care. 2025 Jun;42(3):786-793. doi: 10.1007/s12028-024-02145-5. Epub 2024 Oct 23. |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |