The objectives of the RECONFIG clinical study are to :
The overall goal is to determine predictors and the trajectory of neurological recovery.
Condition or disease |
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Intra Cerebral Hemorrhage |
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 |
Estimated Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Recovery of Consciousness Following Intracerebral Hemorrhage |
Actual Study Start Date : | June 15, 2019 |
Estimated Primary Completion Date : | March 31, 2023 |
Estimated Study Completion Date : | March 31, 2024 |
Group/Cohort |
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Primary ICH
Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.
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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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan Claassen, MD | 212-305-7236 | jc1439@cumc.columbia.edu | |
Contact: Angela Velazquez, MD | 212-305-6071 | agv2113@cumc.columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Jan Claassen, MD 212-305-7236 jc1439@cumc.columbia.edu | |
Contact: Angela Velazquez, MD 212-305-6071 agv2113@cumc.columbia.edu | |
Principal Investigator: Jan Claassen, MD | |
Weill Cornell Medical Center | Not yet recruiting |
New York, New York, United States, 10065 | |
Contact: Hooman Kamel, MD 212-746-0382 hok9010@med.cornell.edu | |
Principal Investigator: Hooman Kamel, MD |
Principal Investigator: | Jan Claassen, MD | Associate Professor of Neurology |
Tracking Information | |||||||||
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First Submitted Date | June 17, 2019 | ||||||||
First Posted Date | June 19, 2019 | ||||||||
Last Update Posted Date | July 18, 2019 | ||||||||
Actual Study Start Date | June 15, 2019 | ||||||||
Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Recovery of Consciousness Following Intracerebral Hemorrhage | ||||||||
Official Title | Recovery of Consciousness Following Intracerebral Hemorrhage | ||||||||
Brief Summary |
The objectives of the RECONFIG clinical study are to :
The overall goal is to determine predictors and the trajectory of neurological recovery. |
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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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Unresponsive and responsive patients diagnosed with ICH. | ||||||||
Condition | Intra Cerebral Hemorrhage | ||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Primary ICH
Subject with acute brain injury will have data collected, including EEG, behavioral, clinical, and outcome measures.
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
150 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | March 31, 2024 | ||||||||
Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03990558 | ||||||||
Other Study ID Numbers | AAAS3574 1R01NS106014-01A1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Jan Claassen, Columbia University | ||||||||
Study Sponsor | Columbia University | ||||||||
Collaborators |
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Investigators |
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PRS Account | Columbia University | ||||||||
Verification Date | July 2019 |