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Brain Ischemia clinical trials

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NCT ID: NCT06370624 Active, not recruiting - Clinical trials for Encephalopathy, Hypoxic-Ischemic

PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

PEDI-REAVASC
Start date: January 17, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores. The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.

NCT ID: NCT05361473 Active, not recruiting - Clinical trials for Newborn Hypoxic-Ischemic Encephalopathy

Evaluation of a PCM Mattress to Treat HIE Infants During Transport

PCMhypo
Start date: August 2013
Phase: N/A
Study type: Interventional

Background the research proposed herein is in line with the Swedish Research Council's current focus on International collaborations and postdoctoral work abroad. In this case the child brain and translational and clinical infant brain research. Neonatal hypoxic ischemic encephalopathy in term infants constitutes a serious health problem, not the least due to its often life-long consequences in the form of cerebral palsy and other forms of brain dysfunction. An estimated 3-5 of every 1000 live term births are affected, a quarter of which with severe symptoms; 10-30% of the affected children do not survive, 30% suffer life-long disabilities. The incidence may be 10-fold higher in the developing world. In Sweden, an estimated 200 children are born each year with hypoxic ischemic asphyxia or oxygen deprivation during delivery of a severity necessitating treatment, in order to reduce future handicap. Not only the brain, but also other organs, such as the heart, liver or kidney can be damaged by hypoxic ischemia. In clinical trials, proof has been obtained that cooling can have positive effects counteracting brain injury induced by oxygen deprivation (asphyxia). Recent research suggests that cooling may also have a positive effect in stroke during the pre-treatment/transportation to hospital phase. PCM. A material with phase change properties (PCM) can be a chemical element, a solution or a substance with high melting energy. It melts/solidifies at a precise temperature and can store considerable amounts of energy (heat) before changing from one phase to another. The study group have used elements or solutions that change between solid and fluid phases within a narrow temperature interval. The most common use of PCM today is for energy storage, accomplished by having the PCM change between solid and fluid phases. Phase changes that include other PCMs, high temperatures and/or gas phases are less useful in medical applications due to the need of either large volumes in a low pressure setting or smaller amounts in a high pressure setting, increasing the risk for mistakes or secondary injury to medical staff or patients. For the clinical purposes of hypothermic treatment described here, the Glauber salt-based PCM in a mattress form developed by the applicant has near ideal properties; it is completely safe, does not cause over-cooling, can be reused many times, eliminates cooling fluctuations, is easy to handle and biodegradable.

NCT ID: NCT05048550 Active, not recruiting - Premature Birth Clinical Trials

Babies in Glasses; a Feasibility Study.

BiG
Start date: September 9, 2021
Phase: N/A
Study type: Interventional

This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses. As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.

NCT ID: NCT04876638 Active, not recruiting - Clinical trials for Delayed Cerebral Ischemia

Minocycline for Aneurysmal Subarachnoid Hemorrhage (MASH)

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

Previous work has demonstrated patients presenting with ruptured aneurysms that develop radiographic and clinical vasospasm have a higher permeability of the blood brain membrane. Matrix metalloproteinase 9 (MMP9) has been studied and recently implicated in both the pathogenesis of the blood brain barrier breakdown and vasogenic edema of ischemia strokes, and is suggested to be an accurate biomarker to predict the onset of cerebral vasospasm after subarachnoid hemorrhage. The therapeutic benefit of minocycline, an MMP9 inhibitor, has been investigated in ischemic stroke population, however its role in the treatment of cerebral vasospasm from ruptured aneurysms remains unknown. Our project has two main goals: to further confirm MMP9 has a reliable biomarker for the onset of cerebral vasospasm, and secondarily to investigate any possible therapeutic benefit that minocycline has in the vasospasm population. Vasospasm continues to be one of the major contributors of morbidity and mortality in the ruptured aneurysm population, and close monitoring of the neurologic exam during the 'vasospasm window' usually requires two weeks in the intensive care unit in most academic settings. As such, if we are better able to predict which patients are at risk of developing vasospasm based on MMP9 levels, we will be better able to anticipate the need for intervention and therefore mitigate the risk of vasospasm induced ischemic strokes, ultimately resulting in better outcomes in the ruptured aneurysm population. Further, if we are able to identify minocycline as a therapeutic agent to deter, or lessen the severity of vasospasm, we can possibly improve neurologic outcomes, decrease hospital stays, ultimately providing an improved and more cost-effective treatment strategy to our patients.

NCT ID: NCT04821726 Active, not recruiting - Cerebral Ischemia Clinical Trials

DEB for Symptomatic Intracranial Atherosclerosis Stenosis

Start date: June 21, 2021
Phase: N/A
Study type: Interventional

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.

NCT ID: NCT04766541 Active, not recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

THE ROLE OF CARDIAC MARKERS IN HYPOXIC ISCHEMIC ENCEPHALOPATHY IN LONG-TERM NEURODEVELOPMENTAL FOLLOW UP

TRCMHIE
Start date: December 30, 2020
Phase:
Study type: Observational

In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured before treatment with the long-term neurodevelopmental score of newborns diagnosed with perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic ischemic encephalopathy (HIE) will be evaluated. Physical examination, laboratory (especially cardiac markers), aEEG findings and diffusion MRI findings of babies who have been hospitalized in the neonatal intensive care unit between 2015-2020 due to respiratory distress and who have undergone perinatal asphyxia but have undergone therapeutic hypothermia treatment will be recorded from their files in the hospital system. The neurological evaluations and neurodevelopmental scores of the babies in the follow-up in the neonatal high risk follow-up clinic after discharge will be recorded from their files.

NCT ID: NCT04063215 Active, not recruiting - Clinical trials for Traumatic Brain Injury

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

Start date: January 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

NCT ID: NCT03985176 Active, not recruiting - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

Start date: June 10, 2019
Phase:
Study type: Observational [Patient Registry]

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.

NCT ID: NCT03962127 Active, not recruiting - Stroke Clinical Trials

MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway

Start date: May 1, 2015
Phase:
Study type: Observational

Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. The investigators have established a cohort consisting of 800 patients with first time ischemic stroke treated at hospitals in Central Norway. The investigators want to study the incidence and prognostic markers for death, recurrent stroke and severe functional deficits during a period of 10 years after the initial ischemic stroke. The investigators want to focus on the impact of physical functioning, the level of physical activity and use of medication for secondary prevention on the incidence of death, recurrent stroke and severe functional deficits. The investigators are especially interested in the importance of fulfilling the treatment targets for blood pressure and cholesterol and the importance of smoking cessation in stroke survivors. Our objective is to improve todays stroke treatment and achieve a more efficient use of the health resources in order to increase survival after stroke maintaining a good physical and psychological function and quality of life.

NCT ID: NCT03913221 Active, not recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Caffeine for Hypoxic-Ischemic Encephalopathy

Start date: July 12, 2019
Phase: Phase 1
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, ~60% of infants with HIE die or have neurodevelopmental impairment. As a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population. Caffeine may offer neuroprotection for infants with HIE by blocking adenosine receptors in the brain and reducing neuronal cell death. In animal models of HIE, caffeine reduces white matter brain injury. Drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of HIE. However, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. Since these drugs reduce injury to the kidney in infants with HIE, they may also reduce injury to the brain. This phase I study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with HIE.