View clinical trials related to Brain Ischemia.
Filter by:Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: - Identify patients at risk of neuromotor, cognitive and epileptic sequelae - Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: - Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment - Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. - Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. - Brain magnetic resonance imaging between 7 and 14 days. - Electroencephalogram (EEG) within 7 days. After discharge study population will perform: - EEG between 3 and 6 months. - Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. - General Movement Assessment at 3 months. - Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. - Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. - Motor performance assessment using Movement ABC between 42 and 48 months.
This observational study aims to detect levels of iron, alpha-synuclein, and soluble lymphocyte activation gene 3 in acute ischemic stroke patients. And to see expressions of iron, alpha-synuclein, and lymphocyte activation gene 3 in the brain tissue of ischemic rats. The main questions it aims to answer are: - Is there an association between iron and alpha-synuclein accumulation in ischemic stroke? - Is there any change in soluble lymphocyte activation gene levels in ischemic stroke and if these levels are related to stroke severity and infarction size? . Can soluble lymphocyte activation gene levels be used as an early biomarker to diagnose ischemic stroke?
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury. The NIRS monitor used in this study will be the Masimo O3 regional oximeter with neonatal sensors. Near-infrared spectroscopy (NIRS) monitoring uses near-infrared light to measure oxygen levels in the brain tissue (cerebral oxygenation). It provides information about blood flow to the brain and the balance between oxygen supply and demand in the brain tissue. It is non-invasive, safe and used routinely to monitor term and premature babies in the neonatal intensive care unit (NICU). This study will recruit two groups of infants admitted to the NICU who are at risk of brain injury in the newborn period, namely: - Term and near-term babies who are undergoing cooling treatment (therapeutic hypothermia) for moderate to severe hypoxic ischaemic encephalopathy (HIE). - Preterm babies who are born extremely prematurely (before 28 weeks of pregnancy). In the term/near-term group, the primary aims of the study are: - To investigate if cerebral oxygenation during and after cooling treatment relates to markers of brain injury detected on detailed brain scans (MRI and MRS scans). - To describe any changes in cerebral oxygenation which occur during and after seizures (fits) in babies undergoing cooling treatment. In the preterm group, the primary aims of the study are: - To investigate if any changes in cerebral oxygenation occurring during skin-to-skin care are different in premature babies with brain injury (bleeding or cysts in the brain seen on ultrasound scan) compared to babies without these changes. - To investigate if cerebral oxygenation at 36 weeks corrected gestational age differs in babies with bronchopulmonary dysplasia (BDP, a chronic lung disease of prematurity) compared to babies without BPD.
The study is a two-center prospective cohort clinical trial. The primary purpose of this trial is to identify the pattern of DKK2 serum levels in ischemic stroke patients after revascularization therapy and determine the correlation between serum DKK2 levels and prognosis.
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials. If no major modifications are made to the protocol as a result of this evaluation, data from these participants will be included for analysis. Aim 1: Evaluate the efficacy of an early, evidence-based, clinical experience-based therapeutic intervention (from the NICU to 12-months corrected age) on improving motor function and reducing severity of motor delays in infants at 12-months corrected age. The investigators hypothesize that the intervention group will demonstrate an average 8-point difference (0.5 standard deviation) compared to the standard of care group. [an 8-point difference is considered a clinically meaningful difference] Aim 2: Evaluate the early effects (i.e., before 12 months) of a therapeutic intervention, provided from NICU to 12-months corrected age, on motor function and severity of motor delay. The Investigators hypothesize that a statistically significant higher percentage of infants in the intervention group will demonstrate improved motor function and reduced severity of motor delays, compared to the standard of care group-assessed using sensors, the NSMDA and TIMP-as early as 3-months corrected age. Aim 3: Evaluate whether an early intervention that focuses on caregiver engagement improves caregiver well-being. The invetigators hypothesize that an intervention that focuses on supporting and addressing the individual needs of the caregiver will improve caregiver well-being. The investigators will evaluate these effects using the PedsQL (Family Impact Module).
This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) results from a complex combination of macro- and microvascular processes. Besides cerebral vasospasms (CVS), DCI is caused by microthrombosis, neuroinflammation, microvascular dysfunction and cortical spreading depolarization.The glycocalyx plays an essential role in regulation of inflammation, oxidative stress and thrombosis, and could be involved in the pathophysiology of DCI. This study is a single-center prospective observational pilot (phase 1) and correlation (phase 2) study recruiting patients with an aneurysmal subarachnoid hemorrhage. The primary aim of the study is to evaluate the feasibility of performing measurements of the glycocalyx using side-stream darkfield (SDF) imaging sublingually and on the conjunctiva, and by sampling blood for analysis of markers of glycocalyx shedding. Moreover, the objective is to determine characteristic Doppler waveform morphologies in DCI patients by means of thorough analysis of transcranial Doppler (TCD) measurements. The secondary objective is to determine whether changes in glycocalyx integrity correlate with the development of DCI and whether these changes are associated with increased inflammation and with variation in TCD signals. Finally, changes in glycocalyx integrity, in TCD waveform morphology and in levels of inflammatory markers will be correlated with patient outcome at 6 weeks and 6 months after ictus.