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

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ClinicalTrials.gov Identifier: NCT02083367
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Niral Patel, OSF Healthcare System

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.

Condition or disease
Hepatic Encephalopathy Cirrhosis Nonalcoholic Steatohepatitis Hepatitis C

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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2015


Group/Cohort
Hepatic Encephalopathy Group
Disease Group
Control Group
Healthy Group



Primary Outcome Measures :
  1. Functional MRI imagining [ Time Frame: 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


Secondary Outcome Measures :
  1. EEG Testing [ Time Frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks. ]
  2. Neuropsychological Testing [ Time Frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks. ]
    WAIS-III PHES Digit Span and Trails

  3. Neurological Examination [ Time Frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks. ]
  4. Serum Ammonia Level [ Time Frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks. ]
    Hepatic Encephalopathy Group only



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Hospital Gastroenterology Clinic.
Criteria

(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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083367


Locations
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United States, Illinois
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
OSF Healthcare System
Investigators
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Principal Investigator: Nisha Bhatia, MD OSF Healthcare System
Principal Investigator: Hrachya Nersesyan, MD OSF Healthcare System

Publications:
10. Coma. New York: Oxford University Press; 2007.
29. Weissenborn, Karin, et al.

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Responsible Party: Niral Patel, MD, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT02083367     History of Changes
Other Study ID Numbers: OSF-14-001
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Hepatitis C
Hepatic Encephalopathy
Brain Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases