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Stroke, Acute clinical trials

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NCT ID: NCT05760846 Recruiting - Stroke, Acute Clinical Trials

Bimanual Motor Skill Learning in Acute Stroke

MLAS4
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The subacute phase of stroke provides a window into how a lesion perturbs sensorimotor functions prior to reorganisation driven by plasticity and neurorehabilitation. The recovery from motor impairment has been extensively studied, but it is currently unknown whether motor skill learning (MSkL) is enhanced or impaired during acute stroke, especially bimanual motor skill learning (bim-MSkL), which likely requires more motor-attentional-cognitive resources than unimanual MSkL. The goals of this project are: to determine the neural substrates critical to achieve proximal and distal bimanual motor skill learning (bim-MSkL) by specifying whether (sub)acute stroke to different brain areas (cortical and subcortical) induce specific deficits in bimanual and/or distal bim-MSkL, which behavioral components are involved in bim-MSkL, and whether damage to the motor, sensory and inter-hemispheric pathways specifically impairs proximal and/or distal bim-MSkL.

NCT ID: NCT05760326 Recruiting - Atrial Fibrillation Clinical Trials

Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients

DICAS
Start date: September 2, 2022
Phase:
Study type: Observational

BACKGROUND AND RATIONALE OF THE STUDY The analysis of the composition of the clot constitutes a promising tool for investigating the possible pathogenetic mechanisms underlying ischemic stroke. This analysis was made possible thanks to the numerous mechanical thrombectomy operations which have now become routine. Several studies have attempted to explore the possible relationship between the primary site of thrombus formation and clot composition, reporting that cardioembolic stroke may have a higher percentage of platelet-rich areas than noncardioembolic thrombosis. However, the data are conflicting and do not seem to support an association between clot histology and etiology. Furthermore, thrombus composition appears to influence thrombolysis and the efficacy of thrombectomy. For example, fibrin-rich thrombi appear to reduce the effectiveness of thrombolytic treatment and require more steps with mechanical thrombectomy treatment. Primary ENDPOINT: Evaluate how clot composition relates to stroke etiology according to the TOAST classification. Secondary ENDPOINT: - relationship between different clot components and the degree of thrombectomy recanalization as defined by treatment modified cerebral ischemia score (mTICI). - relationship between the different components of the clot and the number of steps required to achieve recanalization. - relationship between the different clot components and outcome indicators (NIHSS score and mRS score). TARGET POPULATION Patients with ischemic stroke with occlusion of large intracranial vessels will be included in the study if deemed suitable for mechanical thrombectomy therapy in accordance with national and international guidelines. INCLUSION CRITERIA - age > 18 years; - Patients diagnosed with large vessel occlusion stroke in the emergency room CT Angio-study, undergoing mechanical thrombectomy procedure. - Recovered thrombus available for analysis EXCLUSION CRITERIA ● Lack of written informed consent. MATERIALS AND METHODS The clot will be portioned. Part of the sample will be fixed in a 10% formalin solution (3.7% formaldehyde), part will be frozen in liquid nitrogen. Within 24-48 hours of fixation, formalin-fixed thrombi will be dehydrated by increasing the concentration of ethanol (70%, -80%, -95%, 100%) and paraffin-embedded allowing good preservation of tissue morphology and easy long-term storage. The included samples will be sectioned along the major axis of the thrombus, in slices with a thickness between 4 and 5 µm. Base staining will be used to visualize RBC, PLT and fibrin. - Hematoxylin and Eosin (H&E) will allow visualization of general thrombus structures and identification of aggregates of fibrin/platelets (colored pink), red blood cells (red), and nucleated cells (dark blue). - Martius Scarlet Blue (MSB), selectively stains fibrin (dark pink/red), red blood cells (yellow) and collagen (blue - Mallory-Azan for collagen and phosphotungstic acid hematoxylin for fibrin. - immunohistochemistry to detect the presence of - Platelets (CD42-Gp-Ib+, CD41a-Gp-IIb/IIIa+, CD61-GpIIIa), - white blood cells (CD45+, common leukocyte antigen), or monocytes/macrophages (CD14+, CD1a+, CD68+), - T lymphocytes (CD3+, CD8/CD4+), or natural killers (CD16+, CD56+), or mobile premature endothelial cells and blood progenitors (CD34+), or neutrophils (CD45+, CD16+), or fibrinogen or von Willebrand factor.

NCT ID: NCT05745051 Recruiting - Stroke Clinical Trials

The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic Stroke

Start date: November 8, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the effectiveness and safety of CVA-FLOW, a digital health AI based Telestroke system developed by CVAID Ltd. Company aims to assist certified medical staff to triage acute ischemic stroke patients using dedicated algorithms in order to support application for market approval for CVA-FLOW device.

NCT ID: NCT05735626 Recruiting - Stroke Clinical Trials

Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation

ICI20/00117
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

According WHO, oropharyngeal dysphagia (OD) is a prevalent post-stroke (PS) condition involving the digestive system (ICD-10: I69.391) and an independent risk factor for malnutrition and pulmonary infection; and leads to greater morbimortality and healthcare costs and poorer quality of life (QoL). Currently, OD therapy is mainly compensatory, with low rates of compliance and small benefit, and there is no pharmacological treatment, so new treatments that improve patients' condition are crucial. PS-OD patients present both oropharyngeal sensory and motor deficits, so neurorehabilitation treatments which target both could be optimum. Benefits of paired peripheral sensory stimulation with oral capsaicin or piperine and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) will be studied. Pairing sensory peripheral and central stimulation may produce greater benefits. The main aim of the project is to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients. The investigators will assess the acute application of tDCS/piperine or tDCS/capsaicin in the acute phase of stroke, will improve PS-OD. 2 days randomized crossover study with 60 patients in 3 treatment groups (60 patients in the acute stroke phase divided in 3 study arms). We will assess changes in swallow safety, and neurophysiology of the swallow, hospital stay, respiratory and nutritional complications, mortality and QoL.

NCT ID: NCT05710029 Recruiting - Stroke, Acute Clinical Trials

Cortical Processes During Walking Post-stroke

Start date: May 1, 2023
Phase:
Study type: Observational

The study aims to use novel mobile imaging techniques with high-density electroencephalography (EEG) to quantify cortical processes synchronized to the biomechanics of walking. Here, the study has two aims - the primary aim is to quantify the cortical processes that contribute to gait dysfunction early post-stroke, and the second aim is to determine how cortical processes are mediated by mechanical assistance during early gait training post-stroke. Participants will wear an electroencephalography (EEG) cap to measure brain activity and other non-invasive physiological sensors. Participants will be asked to perform different tasks, such as walking at different speeds and walking with different levels of body weight support.

NCT ID: NCT05652933 Recruiting - Stroke, Acute Clinical Trials

Optimizing Acute Ischemic Stroke Diagnostics Using Artificial Intelligence

AI-STROKE
Start date: December 10, 2021
Phase:
Study type: Observational [Patient Registry]

Prospective observational multi-center study with the aim to organise and simplify the care pathway through a pragmatic approach to acute stroke imaging powered by cutting edge advances in image processing and artificial intelligence.

NCT ID: NCT05649670 Recruiting - Stroke, Acute Clinical Trials

Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT

ASPHALT
Start date: October 16, 2023
Phase: N/A
Study type: Interventional

ASPHALT is an academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. 450 patients with confirmed acute ischemic stroke will be recruited over a 3-year period, with 3-month follow-up.

NCT ID: NCT05603377 Recruiting - Stroke, Acute Clinical Trials

Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). Dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. It is reported that the occurrence rate of post-stroke dysphagia (PSD) is varies widely, ranging from 19% to 81%, the reason may be associated with the type of stroke, the assessment tools, the timing of the assessment, and so on .Dysphagia is associated with pneumonia, malnutrition, dehydration, increased mortality, and poor long-term outcome. It has been shown that early detection of dysphagia allows for immediate intervention and thereby reduces morbidity, duration of hospitalization, and overall health care costs. Oropharyngeal dysphagia (OD) can have a high impact on the general health of affected patients and can produce two main types of complications in patients with post stroke: (1) those caused by impaired efficacy of swallow, present in 25%-75% of patients, which leads to malnutrition and dehydration and (2) impaired safety of swallow which leads to tracheobronchial aspiration that may cause pneumonia in 50% of cases. Both OD and aspiration are highly prevalent conditions in patients with stroke . Dysphagia is more common in hemorrhagic stroke compared with ischemic stroke, so far, most studies have focused on the latter, presumably due to its higher incidence .The recognition of a brain lesion pattern associated with oropharyngeal dysphagia could help to distinguish those patients in need of more in-depth evaluation and the subsequent adoption of preventive measures. However, it is difficult to predict which patients are susceptible to developing swallowing alterations depending on neuroimaging findings. However, the findings have been inconsistent, mainly due to simplification in the classification of brain injuries into a small number of groups, or to the different methods employed in assessing swallowing function

NCT ID: NCT05595876 Recruiting - Stroke, Acute Clinical Trials

Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype

STRIPE
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis. The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot. The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.

NCT ID: NCT05578300 Recruiting - Stroke Clinical Trials

Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific

Start date: October 21, 2022
Phase:
Study type: Observational

As a major breakthrough of acute stroke treatment over the past decade, endovascular thrombectomy (EVT) drastically improved neurological recovery and survival in patients with large vessel occlusion (LVO) ischemic strokes in major clinical trials. Nevertheless, much remained uncertain about the implementation of scientific evidence of EVT into real-world benefits. For instance, healthcare policies that influence critical time-matrices, endovascular thrombectomy techniques that may enhance success rate or prevent complications, or advanced imaging techniques that allow precise prognosis or expansion of treatment populations, should be evaluated. On the other hand, capturing LVO patients who were not able to undergo EVT may reveal the gap between clinical trials and real-world practice in the Asia-Pacific. In this multicenter prospective collaboration across the Asian-Pacific, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.