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临床试验/NCT03990558
NCT03990558招募中不适用

Recovery of Consciousness Following Intracerebral Hemorrhage

Columbia University4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
4
主要终点
Time to clinical command following

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Time to clinical command following

时间窗: Hospital discharge (approximately 3 weeks)

To investigate whether patients will clinically follow commands earlier after the hemorrhage.

Modified Rankin Scale (mRS) Score

时间窗: 6 months

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.

次要结局

  • Modified Telephone Interview for Cognitive Status (TICS) score(6 months)
  • Quality of Life in Neurological Disorders (Neuro-QoL T-score)(6 months)
  • Difference in EEG response rate to verbal commands of the motor imagery paradigm.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Claassen

Professor of Neurology

Columbia University

研究点 (4)

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