Completed

Brain Function and Chemistry Analysis in Chronic Hepatic Encephalopathy Patients

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What is being tested

Data Collection

Who is being recruted

Brain Diseases+11

+ Brain Diseases, Metabolic

+ Central Nervous System Diseases

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2006
See protocol details

Summary

Principal SponsorImperial College London
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2006

Actual date on which the first participant was enrolled.

Hepatic encephalopathy (HE) is a common condition that affects the brain and behavior, often seen in people with liver diseases like cirrhosis. In the UK, cirrhosis is responsible for 4000 deaths annually, and around 500,000 people are believed to have chronic hepatitis C, which can lead to cirrhosis in up to 20% of cases over 20 years. Unfortunately, monitoring this condition objectively has been challenging, and there's no universally accepted standard test for its diagnosis and monitoring. This study aims to address these challenges by using a novel approach that combines magnetic resonance imaging (MRI) sequences to examine the effects of HE on the brain in patients with cirrhosis. In this study, 50 patients will undergo blood tests, a 1-hour MRI brain scan, and psychometric testing, which includes both computer-based and paper-based tests. After these initial assessments, patients will receive L-ornithine L-aspartate (LOLA) treatment orally for 4 weeks. Following this treatment period, they will repeat the blood tests, MRI, and psychometric tests. The study's primary goal is to observe changes in the brain's size, function, and chemistry before and after the anti-encephalopathy treatment with LOLA. By correlating the MRI data with the results of the psychometric testing, researchers hope to determine the sensitivity of the MR techniques in assessing HE and the brain's response to therapy.

Official TitleFunctional Magnetic Resonance Imaging and Spectroscopy of the Brain in Patients With Chronic Hepatic Encephalopathy
NCT00305591
Principal SponsorImperial College London
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesDigestive System DiseasesFibrosisHepatic EncephalopathyLiver DiseasesMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic Insufficiency

Criteria

5 inclusion criteria required to participate
Age 18-65

Biopsy-proven cirrhosis

Clinically stable

Able to give informed consent

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6 exclusion criteria prevent from participating
Ferro-magnetic implants

Claustrophobia

Weight >120kg

Significant renal impairment (Creatinine >150 micromol/L)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Imperial College London

Hammersmith, United KingdomOpen Imperial College London in Google Maps
CompletedOne Study Center