Clinical Research Directory

Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation

This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation after emergency endovascular therapy (EVT).

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke

This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.

Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke

The goal of this clinical trial is to learn if balance training on a moving (dynamic) platform with visual and sound feedback, combined with weak electrical brain stimulation, helps people recover balance and movement after an ischemic stroke with weakness on one side of the body (hemiparesis). The main questions it aims to answer are: * Does the combination of dynamic platform training and active brain stimulation improve balance more than either method alone? * Does it improve independence in daily activities, mobility and walking, and reduce fall risk? * Is the combined treatment safe in the early period after stroke? Researchers will compare four groups: dynamic platform training with active stimulation, dynamic platform training with sham (imitation) stimulation, training on a locked (static) platform with active stimulation, and training on a locked platform with sham stimulation. Participants will: * Receive standard rehabilitation (exercise therapy and physiotherapy) of the same volume in all groups. * Complete 10 sessions of 20-minute platform training over 12 days (5 sessions per week), with active or sham brain stimulation during each session. * Have balance, mobility and neurological tests on Day 0, Day 6 and Day 12.

Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients

Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25\~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to (1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards. Patients with fatigue (FAS\>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.

Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen

Cognitive problems are common after a stroke and must be identified early so that rehabilitation can be initiated to improve outcome. As a comprehensive cognitive assessment is rarely possible during hospitalization, short screening tools are often used. In 2015, a tool developed specifically to screen for cognitive deficits in stroke, the Oxford Cognitive Screen (OCS), was released. Despite the tool now being widely used internationally, we don't know how good it is at finding cognitive problems and know very little about how well it predicts cognitive recovery. In this study, we will assess cognition in 240 stroke survivors using the OCS and detailed cognitive tests in both the early stage (within three weeks of stroke) and the chronic stage (6-9 months post-stroke) to learn more about how well the tool does at measuring cognitive problems and predicting recovery. The study will also inform us on how large a percent of stroke survivors have cognitive impairments in the early stages after stroke and in the chronic stage of recovery.

Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning

Stroke is a leading global cause of death and disability. In 2021 there were 11.9 million incident strokes (10.7-13.2 million) and 93.8 million prevalent stroke survivors (89.0-99.3 million) worldwide. The burden in China is particularly severe: stroke is the leading cause of disability-adjusted life years lost, at 45.9 million, and causes more than 2 million deaths each year. Recurrence is common after a first stroke, with reported recurrence rates ranging from 5.7% to 51.3%; approximately 7.7% of patients recur within 3 months and 10.4% within 12 months, and a cohort study of 500,000 Chinese adults found that 41% (95% CI 41%-42%) of stroke survivors had a recurrence at 5 years. Recurrent stroke is associated with higher mortality, greater disability and increased consumption of health care resources, making secondary prevention after stroke the core element of reducing recurrence and improving prognosis. Current stroke prevention and control systems remain largely reactive. Monitoring relies mainly on the patient's subjective perception after symptom onset, emergency response is triggered by telephone calls, and there is no mechanism for pre-symptomatic active sensing or active intervention at onset. The median onset-to-door time in China is still 180-240 minutes and reperfusion treatment rates (2.4%-7%) lag behind those of developed countries. Existing risk assessment tools such as the Framingham score are static models based on demographic characteristics; they cannot reflect the spatiotemporal evolution of physiological parameters in the 24-72 hours before onset and therefore cannot detect a 'recent high-risk state'. Digital health management is mostly one-way information push without bidirectional, agent-driven interaction, resulting in low patient adherence and warning messages that rarely translate into protective action. Wearable health-monitoring devices combined with agentic artificial intelligence offer continuous, real-time and quantifiable physiological monitoring in everyday life. However, the effectiveness, feasibility and safety of such warning and intervention systems for stroke patients, especially for secondary prevention after discharge, have not been systematically evaluated. This study therefore evaluates a stroke early-warning system based on wearable monitoring and clinical data fusion, in order to provide evidence for a digital management model for stroke prevention.

Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke

Stroke is a major cause of long-term disability, and many stroke survivors experience persistent difficulties moving and using their affected arm and hand. Improving upper limb function is an important goal of stroke rehabilitation. This study aims to investigate whether adding brain-machine interface (BMI) training to conventional rehabilitation improves upper limb motor recovery after stroke. The BMI system uses electroencephalography (EEG) to detect brain activity associated with imagined or attempted hand movements and provides visual feedback through virtual reality (VR). Neuromuscular electrical stimulation (NMES) is also applied to the affected wrist and finger extensor muscles during designated movement tasks. A total of 68 adults undergoing inpatient rehabilitation after ischemic stroke will be randomly assigned to one of two groups. Both groups will receive standard rehabilitation. The experimental group will additionally receive BMI training with VR feedback and NMES, while the control group will receive NMES without BMI or VR feedback. Both groups will complete 12 additional sessions over four weeks. The main outcome will be the change in upper limb motor impairment, assessed using the Fugl-Meyer Assessment for the Upper Extremity (FM-UE). Other measures will assess upper limb activity, muscle strength, and functional independence. The study will help determine whether BMI-assisted training provides additional benefits compared with NMES alone when combined with conventional inpatient stroke rehabilitation.

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

This study is a multicenter, double-blind, placebo-controlled, randomized clinical trial that aims to evaluate the efficacy of probucol on the reduction of the risk of recurrent stroke in patients with symptomatic intracranial or extracranial arterial stenosis.

Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory

This study seeks to use safe, powerful, non-invasive computing tools, including machine learning and advanced neuroimaging analysis, to better understand how stroke affects the brain's network of connections. Using structural MRI, including diffusion-weighted imaging, this study will generate a detailed map of brain pathways to evaluate how strokes in the middle cerebral artery (MCA) territory disrupt the brain's structural networks. In the future, this approach may help physicians better predict recovery, monitor neuroplasticity, and guide rehabilitation decisions after stroke.

Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

Post-stroke Delirium in Ischemic Stroke Patients

This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD). The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) and concomitant moderate-to-severe white matter hyperintensities (WMH) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period. The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score. Secondary endpoints include additional functional and cognitive assessments at week 24. Safety assessments will include all-cause mortality, adverse event (AE), treatment-related adverse event (TRAE), and serious adverse event (SAE). The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.

Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.

Neurological Rehabilitation and Neuroplasticity After Ischemic Stroke

This observational study evaluates the effects of neurological rehabilitation on biological markers associated with neuroplasticity and neurotransmitter profiles in patients after ischemic stroke. The study will include patients at different stages after stroke who undergo neurological rehabilitation as part of their standard care. The aim of the study is to assess whether rehabilitation is associated with changes in neuroplasticity-related markers and neurotransmitter levels, which may contribute to a better understanding of recovery processes after ischemic stroke.

EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia

The goal of this clinical trial is to learn if electroencephalogram (EEG) biofeedback-guided transcutaneous auricular vagus nerve stimulation (taVNS) works to treat swallowing difficulties (dysphagia) in adults after a stroke. It will also learn about the safety of this rehabilitation method and how it helps the brain recover. The main questions it aims to answer are: 1. Does EEG biofeedback-guided taVNS improve the ability to eat and drink by mouth? 2. What medical problems (adverse events) do participants have during the treatment? Researchers will compare EEG biofeedback-guided taVNS (where gentle electrical stimulation to the outer ear is paired with surface brainwave monitoring during swallowing exercises) to conventional taVNS (where electrical stimulation is given at fixed times) to see which method better improves swallowing function. Participants will: 1. Receive standardized swallowing rehabilitation training for at least 30 minutes a day, 5 days a week for 2 weeks. 2. Practice swallowing imagery exercises with non-invasive surface EEG biofeedback monitoring while receiving gentle taVNS on the outer ear for 20 minutes a day, 5 days a week for 2 weeks. 3. Complete swallowing tests, questionnaires, and brain evaluations before treatment, after the 2-week treatment, and at Week 4 for follow-up.

Cilostazol for Prevention of Recurrent Stroke Trial

The goal of this clinical study is to learn if adding a medicine called cilostazol to usual treatment can help prevent another stroke, a heart attack, or death in patients who had a stroke caused by a blocked blood vessel, or a "mini-stroke" (also called a TIA), in the past 6 months. To determine if cilostazol is safe and effective at lowering the chance of strokes, heart attacks and deaths, the study will compare cilostazol to a placebo, a pill that looks the same as cilostazol but has no medicine in it. Participants will: * Be assigned by chance to take either cilostazol or a placebo, along with their usual medicine. * Not know which one they are taking, and neither will the study team, which keeps the results fair. * Be followed for up to 5 years to see if they have a stroke, heart attack, or major bleeding.

Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients

This is a prospective observational cohort study of adult patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. The study acquires multimodal neuromonitoring data - including SedLine quantitative EEG (qEEG) from standard-of-care monitoring, Brain4Care (B4C) noninvasive intracranial dynamics monitoring, and near-infrared spectroscopy (NIRS)-derived cerebral autoregulation (CA) indices where NIRS is already in clinical use - and links these data to bedside physiologic, medication, diagnostic, and clinical outcome variables during standard care. No alteration of clinical management occurs. The study prioritizes aneurysmal subarachnoid hemorrhage (aSAH) patients to characterize the natural history of noninvasive CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14) and provides preliminary data for subsequent interventional study design.

Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package

The aim of this study is to analyze the relationship between the blood biomarker GDF-15 and heart damage after stroke. It is being conducted in France, in the Neurology Department of the Dijon University Hospital (Burgundy). The research is interventional because a biological blood test will be performed, as well as a heart rhythm recording and several cardiac echograms during the hospitalization of the participants and during the follow-up consultation scheduled 4 to 6 months after the stroke. A total of 130 stroke patients will participate in this study. Participation includes 4 visits: * Inclusion visit (within 24 hours of the first stroke symptoms) * visit 1 (within 24 to 72 hours of stroke) * visit 2 (within 48 hours of visit 1) * Visit 3 (approximately 4-6 months post-stroke)

EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease

ERSIAS IIb is a multicenter randomized controlled trial, with a Phase IIb design, to find out whether encephaloduroarteriosynangiosis (EDAS), a type of indirect surgical revascularization of the brain, added to intensive medical management, lowers the rate of recurrent stroke and death compared with intensive medical management alone. The trial enrolls 170 adults who have had a recent ischemic stroke or transient ischemic attack caused by intracranial atherosclerotic disease, with a narrowing or blockage of at least 70% of the intracranial internal carotid artery or the middle cerebral artery and reduced blood flow in the territory of that artery. Participants are assigned at random, in equal numbers, to EDAS plus intensive medical management or to intensive medical management alone, and are followed for 18 to 54 months.

MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke

This randomized, double-blind, controlled clinical trial evaluates the effectiveness and safety of combined mesenchymal stem cell (MSC) secretome and repetitive transcranial magnetic stimulation (rTMS) for motor recovery in patients with subacute ischemic stroke. Participants will be randomized to either an intervention group receiving intravenous MSC secretome combined with high-frequency ipsilesional rTMS or a control group receiving placebo infusion and sham rTMS. The intervention is administered once weekly for 8 weeks. The primary outcome is change in motor function measured using the Fugl-Meyer Motor Scale. Secondary outcomes include changes in quantitative electroencephalography biomarkers, including sensorimotor rhythm, delta-theta-to-alpha-beta ratio, and beta coherence, as well as spasticity assessed using the Modified Ashworth Scale and treatment-related adverse events.

Continuous Dual Aspiration Technique With Zoom System for Stroke

This study is designed to evaluate the effectiveness, safety and clinical performance of ADAPT 2.0, first-line aspiration neurothrombectomy with Zoom System with Continuous Dual Aspiration Technique (CDAT).

Strategy for Improving Stroke Treatment Response

SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders

This is a single-center, prospective, randomized, double-blind, sham-controlled study. It will test whether remote ischemic conditioning (RIC), a non-invasive arm-cuff treatment, can improve insomnia after ischemic stroke and whether adenosine A2A receptors and neuroinflammation are involved. About 136 patients will be enrolled. Eligible participants are 18-80 years old, right-handed, have had a first imaging-confirmed ischemic stroke 3-6 months earlier, have an mRS score ≤3, and report insomnia with a PSQI score \>5. Patients with other sleep disorders, severe medical conditions, or recent use of sleep-affecting medications will be excluded. Participants will be randomly assigned to RIC (cuff pressure 200 mmHg) or sham control (60 mmHg). Both groups will receive treatment twice daily for 90 days. Each session lasts 45 minutes and includes 5 cycles of 5-minute ischemia and 5-minute reperfusion. The primary outcome is the PSQI score at 90 days. Secondary outcomes include PSQI response (≥5-point decrease), insomnia remission (ISI \<8), polysomnographic sleep measures, fatigue, daytime sleepiness, mood, quality of life, blood inflammatory markers, and A2A receptor expression on monocytes. Follow-up will occur at 1, 2, 3, 6, and 12 months. This study may determine whether RIC is a safe, non-drug option for post-stroke insomnia and help clarify its anti-neuroinflammatory mechanism.

Blood PREssure Augmentation in Large-vessel Occlusion Stroke Study

An open label, prospective, single center, pilot trial to assess feasibility and tolerability of short term blood pressure augmentation to minimize infarct progression in acute LVO stroke patients undergoing endovascular therapy.