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Brain Diseases clinical trials

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NCT ID: NCT03806816 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Use of Melatonin for Neuroprotection in Asphyxiated Newborns

MELPRO
Start date: December 13, 2018
Phase: N/A
Study type: Interventional

Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes. The neurodevelopmental consequences of brain injury for asphyxiated term infants include cerebral palsy, severe intellectual disabilities and also a number of minor behavioural and cognitive deficits. However, there are very few therapeutic strategies for the prevention or treatment of brain damage. The gold standard is hypothermic treatment but, according to the literature, melatonin potentially acts in synergy with hypothermia for neuroprotection and to improve neurologic outcomes. Melatonin appears to be a good candidate because of its different protective effects including reactive oxygen species scavenging, excitotoxic cascade blockade, modulation of neuroinflammatory pathways. The research study will evaluate the neuroprotective properties and the effects of Melatonin in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.

NCT ID: NCT03805009 Completed - Clinical trials for Cardiovascular Diseases

Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients

Start date: March 19, 2013
Phase: N/A
Study type: Interventional

To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes. The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.

NCT ID: NCT03796598 Completed - Cirrhosis Clinical Trials

FMT in Cirrhosis and Hepatic Encephalopathy

Start date: July 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of care treatments. Repeated episodes of confusion can make it difficult for patients to function and may result in multiple admissions to the hospital and burden on the family. The investigators have studied using a healthy person's stool to replace the bowel bacteria, called fecal microbial transplant, in small studies with good results. In this trial the investigators propose to perform these procedures using an upper and lower route in Veterans who suffer from this condition and follow them for safety and HE and related hospitalizations over 6 months. The investigators will compare this to placebo treatments and hope that this intervention can improve the health and daily functioning of affected patients.

NCT ID: NCT03786497 Not yet recruiting - Clinical trials for Congenital Heart Disease

Protecting Brains and Saving Futures - the PBSF Protocol

PBSF
Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.

NCT ID: NCT03779672 Completed - Clinical trials for Epileptic Encephalopathy, Childhood-Onset

Memantine for Epileptic Encephalopathy

Start date: February 7, 2019
Phase: Phase 4
Study type: Interventional

This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.

NCT ID: NCT03776994 Active, not recruiting - Clinical trials for Nervous System Diseases

Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine

VEEV
Start date: July 17, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection at escalating doses of 2 μg, 10 μg, and 20 μg as a 2-dose primary series (Day 0, Day 28) with a Day 140 booster dose. The secondary objective of the study is to evaluate immunogenicity of the vaccine at the aforementioned time points

NCT ID: NCT03775538 Completed - Parkinson Disease Clinical Trials

Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study

Start date: July 5, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an extension to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety and tolerability of CDNF in patients with Parkinson's disease when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Long-term safety of the DDS is also being evaluated. All patients will receive monthly infusions of either mid- or high-dose of CDNF for a period of 6 months.

NCT ID: NCT03762902 Terminated - Migraine Disorders Clinical Trials

Predicting Migraine Attacks Based on Environmental and Behavioral Changes as Detected From the Smartphone

Migraine
Start date: April 30, 2019
Phase:
Study type: Observational

This study is conducted at the Henry Ford Health System with Lifegraph's behavioral monitoring technology, to examine the relation between migraine attacks and behavioral and environmental changes as detected from the smartphone sensors. The investigators hypothesize that Lifegraph's technology can predict the occurrence of migraine attacks with high precision.

NCT ID: NCT03751085 Recruiting - Clinical trials for Intracranial CNS Disorder

A Clinical Study on Albert Wong Frame-based Stereotactic Biopsy System for Brain

AWF
Start date: July 18, 2018
Phase: N/A
Study type: Interventional

This study is to establish a new, alternative stereotactic biopsy frame (AW frame) in the field of stereotactic neurosurgery.

NCT ID: NCT03744481 Completed - Clinical trials for Anoxic-Ischemic Encephalopathy

Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

SARNATUN
Start date: May 19, 2019
Phase:
Study type: Observational

There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs. There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia. The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.