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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02083367
Enrollment
12
Registered
2014-03-11
Start date
2013-01-31
Completion date
2015-02-28
Last updated
2015-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatic Encephalopathy, Hepatitis C, Nonalcoholic Steatohepatitis

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.

Interventions

None listed

Sponsors

OSF Healthcare System
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Functional MRI imaginingParticipants 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

MeasureTime frameDescription
EEG TestingParticipants will be followed until all study assessments have been completed, an expected average 4 weeks.
Neuropsychological TestingParticipants will be followed until all study assessments have been completed, an expected average 4 weeks.WAIS-III PHES Digit Span and Trails
Neurological ExaminationParticipants will be followed until all study assessments have been completed, an expected average 4 weeks.
Serum Ammonia LevelParticipants will be followed until all study assessments have been completed, an expected average 4 weeks.Hepatic Encephalopathy Group only

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026