NCT02083367已完成不适用
Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Functional MRI imagining
研究概览
简要总结
Investigating the impact of hepatic encephalopathy on default mode networks within the brain to provide more clues with understanding the physiology of consciousness and predicting the reversibility of comatose states.
详细描述
The proposed study will provide better understanding of the patterns of default mode network (DMN) dysfunction in comatose state of hepatic encephalopathy, may help to further define the boundaries of neuronal circuits involve, and will try to assess the prognostic value of fMRI in reversibility of severe metabolic coma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Patient or legally acceptable representative must understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
- •Age 18 or older at the time of informed consent.
- •Patients with liver cirrhosis attending the gastroenterology department (inpatient or outpatient) with hepatic encephalopathy from various causes of liver failure (i.e. alcoholic, infectious, carcinomatous or toxic).
- •The patients will be selected applying Child Pughs score and West Raven classification for hepatic encephalopathy.
- •All patients participating in the study will undergo a full neurological exam, 30 min routine EEG recording and neuropsychological evaluation along with the f-MRI study.
- •(Hepatic Encephalopathy Group)
排除标准
- •History of alcohol consumption or illicit drug use within past 3 months.
- •Patients with underlying psychiatric or neurologic illness (i.e. schizophrenia, untreated major depressive disorder, epilepsy, neurodegenerative dementia, etc.) resulting in unrelated to encephalopathy impairment of consciousness and/or alteration of normal mental capacity.
- •Patients after head injury or with advanced pulmonary, renal, or other than liver failure metabolic disorder (such as severe hypoxia, hypo/hyperglycemia, metabolic acidosis or alkalosis).
- •Patients requiring sedation for MRI.
- •Pregnant women.
- •(Normal Control Group)
- •Inclusion Criteria:
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Be age 18 or older at the time of informed consent.
- •Subjects must be right handed, be free from any neurological injury, be free from any neurological diseases, be free from any psychological diseases, have a baseline Blood pressure < 140/90, not currently be taking any mind altering medications (including antidepressants, anxiolytics, or opioid/narcotic pain medications), and not have claustrophobia
- •(Normal Control Group)
- •Exclusion Criteria:
- •Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- •History of alcohol consumption 1 week prior to the MRI.
- •Illicit drug use within past 3 months.
- •Patients requiring sedation for MRI.
- •Pregnant women.
- •Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
结局指标
主要结局
Functional MRI imagining
时间窗: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
4 Paradigms: 1. Resting 2. Tactile Touch 3. Motor 4. Auditory
次要结局
- Neurological Examination(Participants will be followed until all study assessments have been completed, an expected average 4 weeks.)
- Serum Ammonia Level(Participants will be followed until all study assessments have been completed, an expected average 4 weeks.)
- Neuropsychological Testing(Participants will be followed until all study assessments have been completed, an expected average 4 weeks.)
- EEG Testing(Participants will be followed until all study assessments have been completed, an expected average 4 weeks.)
研究者
研究点 (1)
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