Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome

NCT ID: NCT02083367

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatic Encephalopathy; Cirrhosis; Nonalcoholic Steatohepatitis; Hepatitis C

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatic Encephalopathy Group

Disease Group

No interventions assigned to this group

Control Group

Healthy Group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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)

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OSF Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Niral Patel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nisha Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare System

Hrachya Nersesyan, MD

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare System

Locations

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Countries

United States

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Other Identifiers

OSF-14-001

Identifier Type: -

Identifier Source: org_study_id