Clinical Research Directory

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.

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).

Optimizing Early Nutrition Support in Severe Stroke-2

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.

Body Composition and Acute Stroke

Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

mSOAR and Early Mortality in Acute Stroke

This observational study aims to evaluate the predictive accuracy of the Modified SOAR score for early mortality in patients with acute stroke. Adult patients presenting with acute stroke at Sohag University Hospitals will be included. Data on clinical presentation, medical history, and relevant laboratory investigations will be collected. The study will follow patients during their hospital stay to determine outcomes related to early mortality. The findings will help improve early risk stratification and management of acute stroke patients.

Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance. The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.

Effect of tDCS Timing on Motor Recovery in Acute Stroke Rehabilitation

This randomized, double-blind, sham-controlled clinical trial investigates how the timing of transcranial direct current stimulation (tDCS) influences functional recovery during acute stroke rehabilitation. Sixty hospitalized patients with confirmed acute stroke will be randomly assigned to one of three groups. Each day, all participants will receive three tDCS sessions: one before, one during, and one after their rehabilitation session. In each group, only one of these three daily stimulations is active, while the other two are sham, allowing a direct comparison of timing effects while maintaining blinding. All participants will complete five consecutive days of conventional rehabilitation combined with the tDCS protocol. Functional, sensory, psychological, and motor outcomes will be assessed at baseline and at the end of the intervention week. The study aims to determine whether the timing of tDCS application influences early post-stroke recovery and to inform the design of future confirmatory trials.

Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke

This study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke. In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Any swallowing problems are screened, and any barriers to eating are identified before dietary support. Patient's food intakes are recorded until the 7th day post-acute to assess their energy intake. Depending on patient's nutritional objectives, a reinforced feeding strategy comprising 2 levels is put in place, in order to prevent malnutrition: in level 1, the dietician tries to meet nutritional requirements orally, while in level 2 he can recourse to artificial nutrition in the event of failure or inability to meet requirements with oral intake alone. This strategy is started immediately after the initial assessment. Intakes are reassessed every 24 to 48 hours by the dietician in order to adapt the nutritional strategy as quickly as possible in order to cover the patient's personnalized nutritional needs. No change in practice was required of the randomised centres in the control group. All patients will be contacted by telephone 30 days after stroke to collect parts of the assessment criteria, while the other criteria will be collected directly from the patient's computerised medical record. Three months after stroke, an evaluation of quality of life and modified Rankin test will be performed. Our hypothesis is that the implementation of an individualized management of early nutritional support, aimed at compensating for the decrease in intake associated with the disease, would reduce mortality at 30 days in patients hospitalised for stroke.

Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial

This study (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. It aimed to investigate the efficacy and safety of administering the PCSK9 inhibitor evolocumab early (within 6 hours) after successful thrombectomy in patients with atherosclerotic large vessel occlusive stroke. The study planned to enroll 60 patients, who were randomly assigned 1:1 to either the "thrombectomy + evolocumab" group or the "thrombectomy alone" group. The primary endpoint was the incidence of early neurological deterioration within 7 days post-procedure (NIHSS score increase ≥2 points from post-operative best or death from any cause); secondary endpoints included 24-hour recanalization failure rate, 90-day functional recovery (mRS score 0-2), changes in serum biomarkers, and safety indicators such as symptomatic intracranial hemorrhage. This study aimed to provide prospective evidence for early intensive lipid-lowering and neuroprotective strategies after thrombectomy.

Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Ischemic Stroke

This study is a first-in-human assessment of safety of using umbilical cord mesenchymal stem cells (UCMSCs) in patients with Acute Ischemic Stroke via a combination of intra arterial (IA) and intravenous (IV) stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IA and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.

SEACOAST 1- SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke

SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, with different forms of GA in patients with acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) undergoing mechanical thrombectomy. The study compares GA with normocarbia (GAN) versus GA with mild hypercarbia (GAH), with a primary outcome of collateral robustness at measured at catheter angiography and clinical efficacy as secondary outcome. It is anticipated that the SEACOAST 1 will be followed by a larger, pivotal trial, SEACOAST 2, with primary clinical endpoints, in which the best method of GA identified in SEACOAST 1 is compared with the alternative strategy of anesthesia care (MAC) with minimal or no sedation. The current study focuses uppn SEACOAST 1, which is to be conducted in University of California, Los Angeles Ronald Reagan Medical Center and Santa Monica Medical Center. All acute stroke patients who arrive to one of these two stroke centers and are deemed eligible for thrombectomy will be considered for the proposed study. Physician-investigators will determine study eligibility. Informed consent to participate in the study will be obtained from legally authorized representatives or competent patients. For non-competent patients without on-scene legally authorize representatives, the consent process will utilize enrollment in emergency circumstances with exemption of informed consent (EFIC).

Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke

This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Patients were screened through the emergency stroke green channel and included if they had an onset within 9 hours, met the criteria for large artery atherosclerosis (LAA) after multimodal imaging screening, received intravenous thrombolysis, and signed informed consent to participate. The study used block randomization (block size of 4), stratified by baseline National Institutes of Health Stroke Scale (NIHSS) score (5-10 vs \>10-20) and onset-to-thrombolysis time (\<4.5 hours vs 4.5-9 hours). Intervention group: received subcutaneous injections of Ilyumumab 420 mg (three syringes) within 24 hours after thrombolysis plus standard drug therapy (including statins). Control group: received conventional statin therapy (atorvastatin 20 mg/day) after thrombolysis. All patients received standardized stroke treatment (initiating antiplatelet therapy 24 hours after thrombolysis) and standardized management of blood pressure and blood glucose. NIHSS scores were assessed every 12 hours within 72 hours post-thrombolysis, and then daily thereafter, to evaluate the effectiveness of combined therapy in reducing early neurological deterioration (END). Blinding: The study is open-label. An independent Clinical Endpoint Committee (CEC) was established, and all clinical endpoint events (END assessment, 90-day mRS scores) were evaluated in a blinded manner by experts who were completely unaware of group assignments.

Using AI Systems to Optimize the Clinical Outcome of Stroke Patients

This project addresses the imminent challenge of providing adequate motor rehabilitation to a growing number of stroke survivors amidst the ageing population, decreasing age of stroke, and shortage of physical/occupational therapists in Hong Kong through AI and precision rehabilitation. To reduce the socioeconomic burden from the stroke survivors' loss of independence and their care (\>HK$15 billion/year), the efficacy of rehabilitation and efficiency of its delivery must be improved. These goals can be achieved by prescribing them with individually tailored rehabilitations predicted to yield maximal functional return. Defining a predictive model for such personalization remains challenging given the immense heterogeneity of stroke. The investigators aim to build an explainable AI system that predicts a subject's recovery potential and the treatment option that may realize this potential based on multi-modal pre-rehab assessments. Data from clinical, neuroimaging, neurophysiological, and multi-omic evaluations will be collected from stroke survivors (N≥400) before they undergo upper limb rehab with usual care, neuromuscular stimulation, robotic training, or acupuncture. Machine learning-extracted data features will be used to train decision-tree and neural-network AI algorithms for robust predictions. As soon as the model is validated, the investigators will deploy it to implement a personalized rehab program in the community. Our model's ability to predict the optimal intervention from a wide spectrum of input modalities distinguishes ours from previous less-than-accurate models. Our interdisciplinary team of 13 PIs with expertise in neurology, PT/OT, acupuncture, electrical/biomed. engineering, robotics, neuroscience, neuroimaging, multi-omics, data science, and clinical trial management will put us in a world-unique position to execute this project successfully and generate opportunities of interdisciplinary education. In the long run, our prediction system will accelerate marketization of new rehab strategies by facilitating their clinical-trial evaluations in more targeted subjects, thereby leading Hong Kong to be a future global hub of innovative rehabilitation.

Isolated Versus Synergetic Muscle Facilitation on Upper Limb Functional Performance in Acute Stroke

This study is a randomized controlled clinical trial that will be carried out to investigate the effect of isolated versus synergetic muscle facilitation on upper limb functional performance in patients with acute stroke. RESEARCH QUESTION: Is there a difference between isolated and synergetic muscle facilitation on upper limb functional performance in patients with acute stroke? It will be hypothesized that: There will be no difference between isolated and synergetic muscle facilitation on upper limb task-oriented training in patients with acute stroke. Treatment procedures: Study group (A): patients will receive a physical therapy program in the form of a range of motion exercise, electrical muscle stimulation, stretching exercise, mental practice with motor imagery, and isolated muscle facilitation using electromyography (EMG) biofeedback for six weeks and followed by task-oriented training of the upper limb for six weeks control group (B): will receive a standard physical therapy program including range of motion exercise, electrical muscle stimulation, Mental practice with motor imagery and stretching exercise, synergetic muscle facilitation for six weeks, and followed by task-oriented training of the upper limb for six weeks.

Ischemic Conditioning During Air tRansport Save penUmbral Tissue

The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.

Stroke Recovery Initiative - Registry for Stroke Research Studies

The Stroke Recovery Initiative is a nation-wide participant recruitment registry that connects people who have had a stroke with researchers who are working to develop new approaches to improve recovery after stroke.

Mirror Therapy for Hand Function Recovery in Acute Stroke

Randomized controlled trial to determine whether mirror therapy (MT), added to conventional physiotherapy, improves upper-limb motor recovery, hand function, spasticity, and range of motion (ROM) in acute stroke compared with conventional physiotherapy alone. Outcomes include ARAT, Motor Assessment Scale, Modified Ashworth Scale, and goniometric ROM.

Evaluating Potential Risk of Choking by Laryngeal Ultrasound in Patients With Acute Stroke

The investigators evaluate the vocal cord movement in patients with acute stroke by ultrasound. The occurrence of choking or aspiration pneumonia will be collected in one year after the index stroke.

The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke

Role of MRI in the Early Diagnosis and Management of Acute Stroke and Its Impact on Turnaround Time in Emergency Settings

This study aims to evaluate the role of stroke protocol in the early diagnosis and management of acute stroke and its effect on turnaround time (TAT) in emergency settings.

Factors and Preferences in Patient Selection of Rehabilitation Care Following Acute Stroke: A Predictive Correlational Study.

Background and Purpose Patients with stroke have to receive the rehabilitation care after medical condition has stabilized. In recent years, the long-term care policy offers more options available for rehabilitation care after stroke. However, the selection of care is mainly based on physcicians' advice. This study explores the factors and preferences in patient selection of rehabilitation care following acute stroke, in order to help clinical health professionals incorporate patients' preferences in patient-centred care to properly arrange the stroke rehabilitation care. Methods This is a cross-sectional and predictive study. Purposive sampling of patients surviving acute stroke is taken in the general ward of a medical center in northern Taiwan. Data are collected with patients' characteristics, National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), Modified Rankin Scale (mRS), and factors and preferences in patient selection of rehabilitation care questionnaire. Data are analyzed using IBM SPSS 26.0 for windows. Demographic and clinical characteristics, family support systems and health care systems are compared between patients' preference in the selections of rehabilitation care. Variables with p \< .05 are included as potential predictor variables in the subsequent logistic regression analysis. The level of statistical significance is set at α=0.05. Expected results Demographic and clinical characteristics, family support systems and health care systems are expected as potential predictors of patients' preference in the selection of rehabilitation care.

The Effects of Chin Tuck Against Resistance Exercise on Acute Stroke Patients With Dysphagia

The aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.

The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL

This is a domain within the ACT-GLOBAL platform trial to compare the effectiveness of early and appropriate pharmacological interventions in acute intracerebral hemorrhage (ICH) to control secondary brain injury. Up to 2000 patients with presumed spontaneous supratentorial intracerebral hemorrhage (ICH) will be followed for 6 months (or death, if prior to 6 months). Adaptive interim analyses will be used, with statistical triggers to determine if any of the interventions are superior to control. The end of the trial is defined as the date that all participants have completed their 6-month assessment. A large amount of preclinical data indicates that the outcome from ICH is linked to the detrimental effects of breakdown substances from brain bleeds. However, there remains a lack of compelling evidence supporting the effectiveness of any pharmacological intervention that can mitigate the secondary cerebral injury. The INTERACT domain aims to assess the effectiveness of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, to standard of care alone, on improving functional outcome in patients with spontaneous supratentorial ICH. Those patients who meet eligibility criteria will be randomized to receive one of four interventions: 1. No deferoxamine mesylate and no colchicine (labeled as control) 2. Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days. 3. Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days. 4. Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days.

Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO

Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.