Active clinical trials for "Brain Diseases"

This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed. The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.

Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious condition causing significant mortality and long-term morbidity, including cerebral palsy and mental retardation. Currently, no treatment exists to repair brain injuries secondary to neonatal asphyxia. The only available treatment for this condition is hypothermia that may prevent but not repair the development of brain injury. The success of this therapy is limited. Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary hypertension), but, surprisingly, its effect on the newborn brain has never been studied systematically. The findings of the investigators in the rat model of term neonatal encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has failed to prevent the development of brain injury.

The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult participants with developmental and/or epileptic encephalopathies.

Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™, EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk, involving them directly in steps trigger through body weight balance. The main aim of this study is to assess the clinical and neuromuscular effects of exoskeleton-based gait rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar characteristics who will conduct a traditional over-ground gait training. In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12 one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the training period. The primary outcome is the distance performed during the 6mwt. A follow up study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.

The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.

The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.

The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.

Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations. Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants. Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger. The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.

This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process, babies get agitated, shiver and are uncomfortable. To treat these side effects morphine is frequently used. CLON is very effective in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to determine if low dose CLON will reduce the incidence of shivering and whether it has short term cardiovascular safety. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow to the brain) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.