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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083367
• Other study ID #: OSF-14-001
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: May 21, 2015
• Start date: January 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

(Hepatic Encephalopathy Group)

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)

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)

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fatty Liver
• Hepatic Encephalopathy
• Hepatitis C
• Nonalcoholic Steatohepatitis

Locations

Country	Name	City	State
United States	OSF Saint Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional MRI imagining	4 Paradigms: Resting; Tactile Touch; Motor; Auditory	Participants will be followed until all study assessments have been completed, an expected average 4 weeks.	No
Secondary	EEG Testing		Participants will be followed until all study assessments have been completed, an expected average 4 weeks.	No
Secondary	Neuropsychological Testing	WAIS-III PHES Digit Span and Trails	Participants will be followed until all study assessments have been completed, an expected average 4 weeks.	No
Secondary	Neurological Examination		Participants will be followed until all study assessments have been completed, an expected average 4 weeks.	No
Secondary	Serum Ammonia Level	Hepatic Encephalopathy Group only	Participants will be followed until all study assessments have been completed, an expected average 4 weeks.	No