Clinical Research Directory

Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke

People living with the cognitive effects of stroke are at risk for recurrent stroke and further cognitive decline. Also problematic is that stroke risk clusters in families and biological family members of people who have ischemic stroke may also be at increased risk of stroke and/or cognitive decline. The primary goal of this study is to test the feasibility of a virtually delivered cognitive strategy training and health coaching program to reduce vascular risk and promote brain health in persons with stroke and their biological family members.

Low-Intensity Monitoring Nursing After Thrombolysis for Acute Ischemic Stroke

This cluster-randomized study compares a lower-frequency post-thrombolysis monitoring pathway with a standard pathway in adults with acute ischemic stroke. The study evaluates nursing workload, nursing care, and clinical safety during the early post-thrombolysis period.

Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.

NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke

This is a randomized, controlled, open-label study of MLC901 (NeuroAiD™ II) in patients with mild to moderate ischemic stroke. Eligible participants will be randomized in a 1:1 ratio to receive MLC901 in combination with standard treatment or standard treatment alone for 12 weeks.

Virtual Physical Activity Seated Exercise - Phase 2

This study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment. Participants will be allocated to either a 10-week seated exercise program or a delayed 2-week Boot Camp program. All seated exercises sessions and assessments will be conducted virtually.

The Fourth Left Atrial Appendage Occlusion Study

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

MR Evidence of Cardiac Inflammation Post-Stroke

The present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (MCA) ischemic stroke, involving the right (n=22) and left (n=22) MCA territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on DWI-MRI.

Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke

This prospective non-interventional cohort study investigates the pathophysiology of Atrial Fibrillation Detected After Stroke or transient ischemic attack (AFDAS) by comparing the autonomic function and inflammation between patients with AFDAS, patients with atrial fibrillation (AF) diagnosed before the ischemic event or known AF (KAF), and patients with normal sinus rhythm (NSR) after 14 day of cardiac monitoring following the event onset.

Statistical Learning as a Novel Intervention for Cortical Blindness

This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual impairments. Our task design is built upon theories of statistical learning to reduce the overall training burden while still producing profound improvements to visual abilities. Efficacy will be first established in visually-intact controls before testing in stroke survivors to assess the feasibility of this form of learning in the damaged visual system.

Neurovascular Product Surveillance Registry

Post market surveillance registry

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)

To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.

Effect of Visual Retraining After Stroke

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

Emergency Stroke Unit for Acute Cerebrovascular Events: A Prospective, Single-arm Trial With a Historical Control Group

Background Reperfusion therapies, i.e., intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are most effective treatments in the management of acute ischemic stroke (AIS) patients. The benefits of reperfusion therapies, however, may be reduced by treatment delays due to tests and examinations and logistic issues. Emergency Stroke Unit (ESU), a new concept of stroke unit locating at the Accident and Emergency Department (AED), equipped with a mobile, low-field MR imaging (lfMRI) scanner for fast diagnosis of ischemic stroke, differentiation of intracranial hemorrhage and identification of large vessel occlusion (LVO), is being tested in Mainland China. It may shorten the door-to-needle time (DNT) for IVT and door-to-groin puncture time (DPT) for EVT, which may hance associate with improved functional outcomes of AIS patients. This is a prospective, single-center, open-label, non-randomized, single-arm study aims to evaluate the safety and efficacy of the ESU workflow using lfMRI in shortening the DNT/DPT and improving functional outcomes in AIS patients, who are eligible for IVT and/or EVT and can be treated within 6 hours after onset, compared with standard practice in Hong Kong; to reveal the changes in the ischemic lesions over a few days after IVT/EVT in these patients, with serial follow-up lfMRI exams.

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.

Stroke Prevention in Young Adults With Sickle Cell Anemia

Sickle cell disease (SCD) is the most common genetic disease, affecting about 25 million people worldwide. Approximately 150,000 Nigerian children are born each year with sickle cell disease (SCD), making it the country with the largest burden of SCD in the world. Recent advancements in care for children with SCA have translated into improved survival of children in both high and low-resource settings. However, more complications of SCD are seen in those who survive to adulthood. Silent cerebral infarcts (SCI) and strokes are among the most devastating complications of SCD, affecting 40% and 10% of children, respectively. The overall goal of this study is to extend the Investigator's successful capacity-building effort in the assessment of neurological morbidity in children with SCD living in northern Nigeria (Kano) to young adults with SCD living in the same region. About 50% of all adults with SCD live in Nigeria. Despite the high prevalence of SCD in Africa, the neurological morbidity is not well characterized, limiting opportunities for primary and secondary stroke prevention strategies. At least 50% of young adults with sickle cell anemia (SCA), the most severe form of the disease, will have SCIs and an estimated 10% will have strokes, based on studies in high-resource settings. In high-resource settings, screening for abnormal transcranial Doppler (TCD) velocities in children with SCA, coupled with regular blood transfusion has resulted in a 92% reduction of relative risk for strokes. Despite this effective strategy, regular blood transfusion therapy does not seem sustainable in sub-Saharan Africa due to shortages and the risk of transfusion transmissible infections. Additionally, there is a lack of evidence-based stroke prevention strategies in young adults with SCA, either in the high-income or in low-resource settings. Based on the foregoing, the Investigators propose to determine the prevalence of neurological injury (overt stroke, transient ischemic attacks, and silent cerebral infarcts) in young adults at the transition age from 16-25 years. The Investigators will also, for the first time, assess conventional risk factors of stroke in the general population to determine whether a different prevention strategy is required to reduce the incidence of neurological injury in this high-risk population.

A Phase Ⅱb Study of XY03-EA Tablets in Acute Ischemic Stroke

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase Ⅱb/Ⅲ clinical study to evaluate the efficacy and safety of XY03-EA tablets, a novel oral neuroprotective agent, and explore the dose-response relationship in patients with acute ischemic stroke. In the Phase Ⅱb stage, 360 eligible subjects were enrolled and randomly assigned to four XY03-EA dose groups and one placebo group in a 1:1:1:1:1 ratio. The primary endpoint was the proportion of patients with a modified Rankin Scale (mRS) score ≤ 1 at Day 90 after the start of study treatment.

Trustworthy Artificial Intelligence for Improvement of Stroke Outcomes

Stroke is a leading cause of death and disability worldwide. The clinical validation of explainable and interpretable Artificial Intelligence (AI) solutions to assist a timely, personalised management of the acute phase of stroke, would have a major impact since it can greatly reduce the disability levels of patients. Also, the prediction of long-term outcomes is a crucial factor as it may determine critical decisions such as the discharge destination for the patient. Moreover, compliance with guideline-based secondary stroke prevention has been demonstrated to reduce stroke recurrence, but currently, only 40% of patients are adherent to preventive treatments 3 months after stroke. Therefore, patients´ outcomes can improve with proper patient communication and engagement packages. AI may have a dramatic impact on stroke patient journey, improving predictions, resulting in a better choice of secondary stroke strategies, as well as using evidence-based information to promote better adherence to treatment and reduction of vascular risk factors. The aim of this multicentre observational prospective study is to develop and validate AI-based tools to predict short and long-term outcomes in ischemic stroke patients. Specifically, this study aims to demonstrate the accuracy of AI models in predicting the functional outcome of ischaemic stroke patients as measured by the National Institutes of health Stroke Scale (NIHSS, 0-42) and the modified Rankin Scale (mRS, 0-6) scores at hospital discharge and at 3, 6 and 12 months after discharge. Prospective ischemic stroke patients from 3 Large European centres will be recruited. The training and testing of local AI models will be performed using hospitalization data, collected during the standard of care procedures for stroke patient pathways, and outpatient monitored data from a remote home-care system (NORA app) during the follow-up after discharge. These local models will then be integrated into a federated learning system, where only a global AI model, derived from combined insights of all local models, is shared across participating hospitals. The individual local models and the original data are not shared, ensuring data privacy and security. The accuracy and performance of prospectively optimized AI models in predicting clinical outcomes over a 12-month follow-up period will be evaluated and compared to the actual outcomes of the patients.

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.

Rehabilitation Program Dedicated to Post-stroke Lateropulsion Including Exoskeleton Assisted Exercises

Lateropulsion is a deficit in the body orientation with respect to the vertical in the coronal plane, defined by the presence of one of the three signs: lateral body tilt, active pushing from the sound limbs, and resistance to passive corrections. The lateral body tilt is the cardinal sign, the frequency of the 2 other signs increasing with lateropulsion severity (most dramatic forms called pusher syndrome in the past). Lateropulsion is frequent after stroke, and represents the main factor underpinning balance and gait disorders at the subacute phase. After hemisphere stroke lateropulsion is caused by a bias in the internal model of the verticality in the frontal plane, individuals unconsciously aligning their body posture on a tilted verticality representation. Pilot studies suggested the possibility to recalibrate the internal model of verticality, biased by stroke, and to improve individuals' uprightness. The investigators expect that a specific rehabilitation program combining technics devoted to lateropulsion, and comprising exoskeleton (Atalante) assisted balance exercises could help recalibrate the internal model of verticality and alleviate lateropulsion. The primary objective is to test the hypothesis that a 3-week specific lateropulsion rehabilitation program (15 sessions of 30 minutes including exoskeleton and a rehabilitation focused on the vertical body orientation in the frontal plane) improves the visual vertical (VV), the most used test to assess verticality perception.

Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

Vision Loss Impact on Navigation in Virtual Reality

The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving. Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow).

PRecisiOn Medicine In StrokE: Evolution of Plasma Brain-Derived Tau in Acute Stroke

The investigators recently identified Brain-derived tau (BD-tau) as a sensitive blood-based biomarker for brain injury in acute ischemic stroke: in patients with acute ischemic stroke, plasma BD-tau was associated with imaging-based metrics of brain injury upon admission, increased within the first 24 hours in correlation with infarct progression, and at 24 hours was superior to final infarct volume in predicting 90-day functional outcome. While informing on the relation of BD-tau with imaging-based metrics of brain injury, this cross-sectional study was restricted to BD-tau assessments upon admission and at day 2 and could not inform on key characteristics of the evolution of plasma BD-tau, including when exactly it starts to rise, how long it continues to rise, and how it is determined by infarct characteristics as well as comorbidities. Here, the investigators aim to assess plasma BD-tau every hour from admission to 48 hours after onset to evaluate the hypothesis that BD-tau rises immediately after onset and plateaus between three and 48 hours after onset.

Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials

VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.

Study of Circulating Monocytes in Patients With Ischemic Vascular Disease

The purpose of this research study is to discover the functions of circulating white blood cells, called monocytes, and associated circulating substances in heart attack and ischemic stroke patients. Ischemic Strokes (clots) occur as a result of an obstruction within a blood vessel supplying blood to the brain. A type of monocyte carrying a surface marker called "P2X4" helps the immune system sense and respond to danger signals from the body such as heart muscle and brain tissue injuries. The researchers expect to learn more about how these monocyte cells react to heart and brain tissue injury, and how the cells may then produce proteins or other chemical substances which promote the healing of heart muscle after heart attack and brain tissue after an ischemic stroke.