Brain Function and Chemistry Analysis in Chronic Hepatic Encephalopathy Patients
Data Collection
Brain Diseases+11
+ Brain Diseases, Metabolic
+ Central Nervous System Diseases
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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