SONOlysis in Prevention of Brain InfaRctions During Internal Carotid Endarterectomy
Internal Carotid Artery StenosisSONOBIRDIE Trial is a randomized, single-blind, sham-controlled study designed for a demonstration of the safety and effectiveness of sonolysis (continual transcranial Doppler (TCD) monitoring) in reduction of risk of stroke or transient ischemic attack (TIA), brain infarctions and cognitive decline using a 2-MHz diagnostic probe with a maximal diagnostic energy on the reduction of risk of brain infarctions by the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) in patients with ≥ 70% symptomatic or asymptomatic internal carotid artery stenosis. The sample size is based on an expected 2.5% reduction of ischemic stroke, TIA, and death during the 30-day postoperative period in the sonolysis group (estimated prevalence, 1.5 %) compared to the control group (estimated prevalence, 4 %). Pre-study calculations showed that a minimum of 746 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10 % would be lost to follow-up or refuse to participate in the study. Consecutive patients will be assigned to the sonolysis or control group by a computer-generated 1:1 randomization. In patients randomized into sonolysis group, middle cerebral artery segment in a depth of 55 mm will be continuously monitored during intervention using a diagnostic 2-MHz TCD probe with a maximal diagnostic energy. In patients randomized into control group, the TCD probe will be fixed in a required position using a special helmet as in sonolysis group patients, but middle cerebral artery segment in a depth of 55 mm will be only localized using a diagnostic 2-MHz TCD probe with a maximal diagnostic energy and the TCD monitoring will be stopped afterwards. Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA with consecutive reduction of ischemic stroke, TIA or death, and the number and volume of brain infarcts, can lead to the increase of the safety of CEA in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA can be treated using these methods in the future.
Arm Boot Camp Study: Evaluation of a Program to Increase Upper Limb Recovery After Stroke
StrokeCerebral Infarction9 moreThis study will examine the feasibility and effect of a program that combines exercise and feedback from a wearable device on upper limb movement practice and function in individuals with stroke.
Fluoxetine Opens Window to Improve Motor Recovery After Stroke
StrokeCerebrovascular Accident8 moreThe FLOW trial is a randomized placebo-controlled trial analyzing the effect of coupling an anti-depressant, fluoxetine (Prozac), and exercise to improve motor recovery following a stroke.
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
StrokeIschemic Stroke4 moreA randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.
Determining Optimal Post-Stroke Exercise (DOSE)
Cerebrovascular AccidentStroke8 moreThe investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke
Ischemic StrokeStroke1 moreThe primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a medium dose of IV rt-PA plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.
Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke
Brain InfarctionMore than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders. Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these effects very shortly after initiation. The aim of the study is to test the feasibility of early non-invasive CPAP treatment starting in the first night after stroke onset, and to test its efficacy in a randomized clinical trial. 50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard care PLUS CPAP treatment or standard care only. All patients randomized to the intervention group will receive CPAP therapy for the first three nights after stroke. In the fourth night, a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned to the intervention group with a respiratory distress index > 10/h will be treated further on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be performed to determine the size of the infarction. The NIHSS score will be used to assess clinical short-term outcome on day 4 and day 10. After three months, the outcome will be determined using the modified Rankin scale. As CPAP therapy may be more laborious for the provider, the additional work-load will be documented using pre-specified scales. Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients and that the additional work load will not outweigh the benefits. Secondary hypothesis is that patients assigned to the treatment group have smaller infarctions on MRI and less neurological deficits at 3 months after stroke. Patients entering the study will be investigated by transcranial Doppler ultrasound in case they have sufficient temporal bone windows for insonation and no stenosis or occlusions of major brain supplying arteries by the time of investigation that disturb the intracerebral blood flow. All intracranial arteries will be assessed before treatment, after treatment and on day 8 after the insult. Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new software algorithm developed by NHSi, to investigate microcirculatory information from the flow spectra of the major intracranial arteries. The data from this post-hoc analysis are compared with the data of the polysomnography and with treatment. Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between treated patients and controls.
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)...
StrokeBrain InfarctionThe primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.
Stroke Telemedicine for Arizona Rural Residents Trial
StrokeCerebral Infarction5 moreThe STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.
Home-based Exercises for Patients With Stroke
Cerebrovascular DisordersBrain Infarction2 moreThe aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke. The hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.