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Brain Diseases clinical trials

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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: June 1, 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.

NCT ID: NCT06356233 Not yet recruiting - Clinical trials for STXBP1 Encephalopathy With Epilepsy

Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy

FIMBEX
Start date: May 1, 2024
Phase:
Study type: Observational

This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF).

NCT ID: NCT06354829 Not yet recruiting - Kidney Diseases Clinical Trials

Medical Images Collection Research

MEDICALBUM
Start date: April 2024
Phase:
Study type: Observational

This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.

NCT ID: NCT06337864 Not yet recruiting - Metabolic Disease Clinical Trials

Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria

Start date: May 2024
Phase: N/A
Study type: Interventional

This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted.