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Brain Diseases clinical trials

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NCT ID: NCT02022137 Completed - Liver Cirrhosis Clinical Trials

Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy

Start date: October 2013
Phase: N/A
Study type: Interventional

As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.

NCT ID: NCT02019784 Completed - Liver Cirrhosis Clinical Trials

Randomised Controlled Trial of Mechanistic Effects of Rifaximin in Cirrhosis and Chronic Hepatic Encephalopathy

RIFSYS
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Patients with cirrhosis are particularly prone to infection which is frequently a precipitant of hepatic encephalopathy, renal failure and circulatory collapse. Bacterial infections are of particular concern in patients with cirrhosis because they are poorly tolerated. Sepsis and associated endotoxaemia whereby bacteria produce inflammatory particles occur in approximately 40% of hospitalized patients with cirrhosis and is a major cause of death. Gut-derived and blood-borne pathogens can induce an inflammatory response within the liver and spleen, which are the major organs that remove bacteria and their endotoxin (such as lipopolysaccharide - LPS and bacterial DNA itself) from the bloodstream. Several mechanisms have been identified and proposed in this process which depends upon a balance between the barrier functions of the gut and the 'detoxifying' capacity of the liver. People with established liver cirrhosis have been shown to have escape of endotoxin into the bloodstream produced by bacteria that reside in their intestines, which becomes more permeable or 'leaky'. Gut dysfunction is defined by changes in the types of bacteria within the gut and in overall permeability allowing bacterial products which would otherwise be contained within the gut to travel into the bloodstream and lymphatic system with detrimental effects elsewhere in the body. This passage of bacterial products is termed bacterial translocation, and it's effects on the liver and general immune system can be then be measured. It has now become recognised that certain types of white blood cells such as neutrophils and monocytes become dysfunctional and this predisposes to infection and may also have a more direct pathogenic role in hepatic encephalopathy. Thus neutrophil and monocytes may be a novel pharmacotherapeutic target in a condition where current therapies such as bowel aperients (e.g. lactulose) are inadequate. A therapeutic strategy utilising Rifaximin, a non-absorbable antibiotic, to modulate gut bacterial which produce ammonia, a chemical known to be important in the cause of hepatic encephalopathy, could potentially lower gut-derived systemic inflammation, endotoxaemia, infection and organ dysfunction in this population improving outcomes and prolonging transplant-free survival. We therefore plan to test if Rifaximin positively affects markers of immune dysfunction in patients with liver cirrhosis experiencing chronic hepatic encephalopathy after 30 days of treatment, as our primary research question. Positive results from this study would support further trials into the potential benefit of using Rifaximin to improve immune function, as well as reduce the recurrence of hepatic encephalopathy, in patients with liver cirrhosis.

NCT ID: NCT02019147 Completed - Asphyxia Clinical Trials

BiHiVE2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.

BiHiVE2
Start date: March 2012
Phase:
Study type: Observational

Despite recent advances in the care of mothers and newborn infants, many infants (approximately 20 per 1000 live births) continue to need resuscitation at birth. A proportion of these infants will have sustained significant injury through interruption of their blood and oxygen supply prior to delivery (perinatal asphyxia). In 2-3 babies per 1000 this will lead to brain swelling and the risk of long term brain injury called neonatal hypoxic-ischaemic encephalopathy (HIE). HIE remains a cause of neonatal death and long term disability. Early and accurate prediction of outcome would allow us to intervene during the window of the first 6 hours following birth, prior to secondary reperfusion and secondary brain injury. Estimating severity of injury can be difficult in newborn infants. Condition at birth does not predict neonatal, or longer term outcome. Biomarkers which could be measured at the time of birth and analysed at the bedside would offer these infants the best chance of timely and effective intervention. Through the BIHIVE study we have identified a number of predictive biomarkers in hypoxic-ischaemic encephalopathy. These markers are present in umbilical cord blood and have been identified through proteomic and metabolomic analysis of a stored biobank of samples from a recruited cohort of infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy. We now wish to validate these biomarkers in an additional cohort, and will continue to explore new biomarkers in our stored biobank of umbilical cord samples. In addition we wish to assess our ability to predict neurodevelopmental and behavioural outcome in these infants. In this way we will determine the most robust biochemical and clinical markers for the prediction of early and medium term outcome in HIE. This study will establish the evidence base and validation of these biomarkers to the point where they can be developed into a bedside diagnostic algorithm which can be used in the labour ward to immediately identify those infants at risk of HIE in time to prevent secondary damage.

NCT ID: NCT02017119 Completed - Cirrhosis Clinical Trials

Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients

Start date: January 2011
Phase: Phase 2
Study type: Interventional

Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low, due to side effects such as diarrhea, distention, etc.

NCT ID: NCT02016196 Completed - Cirrhosis Clinical Trials

Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

PRPET
Start date: September 2013
Phase: Phase 3
Study type: Interventional

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

NCT ID: NCT02003183 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy

Start date: March 2013
Phase:
Study type: Observational

This project was designed to determine brain imaging patterns using 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) with positron emission tomography (PET) in participants with suspected Chronic Traumatic Encephalopathy (CTE), a progressive degenerative disease of the brain found in people with a history of repetitive traumatic brain injuries (TBIs), characterized by personality, behavioral, and mood disturbances, cognitive impairment, and sometimes motor symptoms. Currently, CTE can only be definitely diagnosed from neuropathological examination of the brain after autopsy. Developing tools to assist in the detection of this condition in living individuals at risk would facilitate research focusing on discovering potential prevention and treatment strategies.

NCT ID: NCT01993316 Not yet recruiting - Brain Diseases Clinical Trials

Neurofeedback Using TMS as an Assessment Tool

Start date: December 2013
Phase: N/A
Study type: Interventional

Neurofeedback can be described as a form of biofeedback which is based on recording brain activity; usually by using scalp EEG. Neurofeedback has been used for 40 years as a therapeutic treatment for many neurological conditions including epilepsy, attention deficit hyperactivity disorder and also to improve mental performance in healthy subjects. Participants can "see" their brain activity via the EEG readings and receive positive feedback (visual or auditory) to help them consciously shape their brain waves into the desired patterns. sLORETA, which is speciliazed computer program to analyze EEG results, will be used in conjuntion with EEG to study the effect of neurofeedback on the brain activity of healthy subjects. In this study we will investigate the effect of neurofeedback training using sLORETA, which is a specific method to measure brain waves. We will measure the effect on both brain hemispheres both before and after neurofeedback training.

NCT ID: NCT01966419 Completed - Clinical trials for Hepatic Encephalopathy

Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

STOP-HE
Start date: January 7, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

NCT ID: NCT01963650 Terminated - Clinical trials for Nervous System Diseases

Natural History Study of Children With Metachromatic Leukodystrophy

Start date: November 2, 2015
Phase:
Study type: Observational

The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).

NCT ID: NCT01962233 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.