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Brain Diseases clinical trials

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NCT ID: NCT06448780 Not yet recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Dose Optimization of Caffeine for HIE

Start date: November 2024
Phase: Phase 1
Study type: Interventional

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

NCT ID: NCT06447701 Not yet recruiting - Stroke Clinical Trials

Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis

IRIS-sICAS
Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.

NCT ID: NCT06447155 Not yet recruiting - Feeding Patterns Clinical Trials

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH. The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.

NCT ID: NCT06429007 Not yet recruiting - Infant Development Clinical Trials

A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.

NCT ID: NCT06425380 Not yet recruiting - Cirrhosis Clinical Trials

Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy. The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.

NCT ID: NCT06412653 Not yet recruiting - Epilepsy Clinical Trials

Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders

ZINCGNAO1
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. The main questions it aims to answer are: - Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy? - Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients. Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.

NCT ID: NCT06402123 Not yet recruiting - Clinical trials for Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

A Phase 2b Study of Zagociguat in Patients With MELAS

PRIZM
Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

NCT ID: NCT06380192 Not yet recruiting - Clinical trials for Developmental and Epileptic Encephalopathy

Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data

DEE-RETRO
Start date: May 1, 2024
Phase:
Study type: Observational

Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity. The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.

NCT ID: NCT06378515 Not yet recruiting - Brain Diseases Clinical Trials

Physical Activity, Sleep and Brain Health Based on the Glymphatic System

Start date: May 2024
Phase:
Study type: Observational

This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer.

NCT ID: NCT06368648 Not yet recruiting - Stroke Clinical Trials

CoMind Early Feasibility Study

CoMind EFS
Start date: June 2024
Phase:
Study type: Observational

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.