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Brain Imaging in Patients With Chronic Liver Disease and Functional Impairment.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305591
First Posted: March 22, 2006
Last Update Posted: May 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Royal College of Physicians
The Paddington Charitable Trust, St Marys, London (2 year fellowship)
University of London
Information provided by:
Imperial College London
  Purpose

Hepatic encephalopathy (HE) is a frequent complication of chronic liver disease (cirrhosis) and involves a wide spectrum of problems from mild impairment of reaction times in driving and operating machinery through to disturbances in mood, behaviour and conscious levels.

Magnetic resonance imaging (MRI) is a method of obtaining pictures of the inside of the body. Patients with liver disease have previously been studied with MRI which has highlighted changes in the brain. This research aims to highlight some of the differences in the way that the brain functions in patients with liver disease. Using our new, more powerful MRI scanner, with more sophisticated techniques we hope that the novel combination of MRI techniques can objectively detect the presence of , and monitor HE.

Study hypothesis: Hepatic encephalopathy (HE) is a reversible, metabolic disturbance of the brain, associated with low grade brain swelling and disturbances of the chemical balance within the brain, resulting in functional impairment, the presence of which MR imaging can detect with sufficient sensitivity to monitor the changes that may occur over time in response to treatment.


Condition Intervention
Cirrhosis Hepatic Encephalopathy Drug: l-ornithine l-aspartate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Magnetic Resonance Imaging and Spectroscopy of the Brain in Patients With Chronic Hepatic Encephalopathy

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • All enrolled patients will be given 4 weeks of treatment. Both MRI and functional changes will be observed.

Estimated Enrollment: 50
Study Start Date: March 2006
Study Completion Date: October 2007
Detailed Description:

Hepatic encephalopathy (HE) is a common neuropsychiatric abnormality, complicating the course of liver disease patients. In the UK, cirrhosis accounts for 4000 deaths per year, and 500,000 people are thought to be infected with chronic hepatitis C, of which up to 20% will develop cirrhosis over 20 years. The condition has been difficult to monitor objectively.

Despite the fact that the syndrome was probably first recognised two thousand years ago, the exact pathogenesis still remains unclear. It is thought to represent a reversible disturbance in brain chemistry and consequent brain swelling, in response to blood containing unfiltered gut-derived toxins entering the cerebral circulation. There is no recognised 'gold standard' test to diagnose and monitor this important, disabling condition. I have developed a novel combination of magnetic resonance imaging (MRI) sequences at 3 Tesla to study the effects of hepatic encephalopathy on the brain in patients with cirrhosis.

We propose to investigate alterations in brain size, function and chemistry before, and then at intervals after 4 weeks anti-encephalopathy treatment with L-ornithine L-aspartate. This will enable the assessment of both the baseline brain alterations of the cohort and the brain's response to therapy and correlation with their clinical response. As such this longitudinal study would allow us to define the sensitivity of the MR techniques.

Each of 50 patients will have blood tests, a 1 hour MRI brain scan and psychometric testing. The psychometric testing will be performed with both a computer-based battery and conventional paer-based tests. They will then be given L-ornithine L-aspartate (LOLA) to take orally for 4 weeks and have repeat blood tests, MRI and psychometric tests.

We will then determine if there is a correlation between the MR data and the results of the psychometric testing.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65
  • Biopsy-proven cirrhosis
  • Clinically stable
  • Able to give informed consent
  • Fluent English (required for psychometric testing)

Exclusion Criteria:

  • Ferro-magnetic implants
  • Claustrophobia
  • Weight >120kg
  • Significant renal impairment (Creatinine >150 micromol/L)
  • Poorly controlled Diabetes (particularly type I with microvascular complications)
  • Alcohol: if alcoholic liver disease is the aetiology of their liver disease they should be abstinent. Otherwise less than 20g per day.
  Contacts and Locations
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): NCT00305591


Locations
United Kingdom
Imperial College London
Hammersmith, London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Royal College of Physicians
The Paddington Charitable Trust, St Marys, London (2 year fellowship)
University of London
Investigators
Principal Investigator: Simon D Taylor-Robinson, MBBS, FRCP Imperial College London & St Mary's Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00305591     History of Changes
Other Study ID Numbers: 04/Q0406/161
First Submitted: March 21, 2006
First Posted: March 22, 2006
Last Update Posted: May 29, 2015
Last Verified: January 2008

Keywords provided by Imperial College London:
magnetic resonance imaging
magnetic resonance spectroscopy
functional magnetic resonance imaging
cirrhosis
hepatic encephalopathy
l-ornithine l-aspartate

Additional relevant MeSH terms:
Fibrosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs