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Completed

NCT Number: NCT02083367

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

(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.

Treatment and study plan

Primary outcomes

  1. Functional MRI imagining

    Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.

    4 Paradigms:

    • Resting
    • Tactile Touch
    • Motor
    • Auditory

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

OSF Healthcare System

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 11, 2014
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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