Clinical Research Directory

The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up.

Stroke is a disease that primarily affects older adults and, with an estimated 64,000 deaths in 2024, is one of the leading causes of death in Germany. Estimates of its prevalence and the burden of disease within the German population are therefore essential for calculating future healthcare needs and guide health policy planning. When the first stroke units (SU) began to emerge in Germany in 1994, health insurers raised the question of the total number of stroke patients requiring care. Unfortunately, at that time there were no reliable figures available to determine the nationwide need for stroke units. This marked the birth of the Erlangen Stroke Registry (ESPro). For 32 years (1994-2026), ESPro has been continuously collecting data on the epidemiology, clinical course, and care of stroke and dementia, two of the most common diseases. The ESPro is designed as a regional, population-based registry that includes, as far as possible, all diagnosed strokes-that is, both hospitalized and non-hospitalized patients-regardless of age group or severity of the condition. Patients enrolled in the city of Erlangen undergo close monitoring of their clinical course and are followed up at intervals of 3 and 12 months, and then annually for the rest of their lives. This long-term follow-up enables comprehensive health services research on stroke, a widespread disease. Direct information on the course of the disease, its treatment, and care can be gleaned from registry data and incorporated into preventive medicine, treatment, and care planning.

Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis. Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear. The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.

Development and Validation of a Prognostic Model for Neurocritical Patients Using Multimodal Brain Monitoring

This study aims to develop and validate a prognostic model for neurocritical patients using multimodal brain monitoring data. By combining data from various monitoring techniques such as EEG, TCD, and NIRS, this model will help predict 90-day outcomes (awake, comatose, or deceased) and support personalized treatment decisions. The study is observational and involves no experimental interventions.

Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy

Postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. Furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. Thus, those patients with glycemia values \< 155 mg/dL during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in miRNA expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema. The main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.

Derivation and External Validation of the "FORECAST-PC" Prediction Scores

This study aims to develop and externally validate machine learning prediction models (FORECAST-PC) to determine 90-day functional outcomes for patients suffering from acute ischemic stroke in the posterior circulation who are selected for endovascular thrombectomy (EVT)

Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.

Early Identification and Diagnosis of BAD-related Stroke

Branch atheromatous disease (BAD)-related stroke is an important subtype of acute ischemic stroke involving penetrating arteries and is associated with early neurological deterioration. Early recognition and standardized diagnosis remain challenging in routine clinical practice because clinical symptoms are often non-specific and the diagnosis requires integrated clinical and imaging assessment. This multicenter prospective observational study will collect demographic, clinical, laboratory, electrocardiographic, ultrasound, and multimodal neuroimaging data from adults with acute ischemic stroke within 1 week of symptom onset. Participants will receive routine clinical care determined by their treating physicians; no treatment or management strategy will be assigned by the study protocol. An independent central clinical-imaging adjudication committee will classify participants as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria. The study aims to develop and externally validate artificial intelligence-assisted screening and diagnostic models for BAD-related stroke and to evaluate their discrimination, calibration, and potential clinical utility.

Neurologic Stem Cell Treatment Study

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

HR-MRI-Directed Tirofiban Therapy for Late-Window Acute Ischemic Stroke (TIAN)

This study aims to address the existing clinical challenges by introducing high-resolution magnetic resonance vessel wall imaging (HR-MRI), an advanced imaging technology, to achieve precise etiological classification in patients with acute ischemic stroke (AIS) beyond the time window. HR-MRI allows clear visualization of intracranial arterial wall structures and direct identification of key pathological features of the culprit vessel, including atherosclerotic plaques, vascular wall remodeling, and intracranial hemorrhage, thereby enabling reliable differentiation between intracranial atherosclerotic large artery atherosclerosis (ICAS-LAA) stroke and other etiological subtypes such as cardiogenic embolism. Based on the latest clinical demands and advances in imaging technology, this study intends to evaluate the efficacy and safety of tirofiban in patients with ICAS-LAA stroke beyond the time window under the precise guidance of HR-MRI. It is expected to provide high-level evidence-based medical evidence for this specific patient population and further optimize clinical diagnosis and treatment strategies.

D-dimer Prognostic Marker of Cerebral Infarction After Revascularization Procedure

Cerebral infarction is the leading cause of acquired disability in adults. Absence of biological marker used in current practice and identified as a prognostic factor for recovery. D-dimers are degradation products of stabilized fibrin translating an activation of coagulation whatever the cause. Studies have shown that increased D-dimer levels in patients with MI is associated with a higher mortality rate, the link with post-intervention non-revascularization has been demonstrate. The purpose of this project is to search for a correlation between the level of D-dimer and the degree of recovery evaluated by the NIHSS score

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

The aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. Participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.

Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation

Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Treatment options during this period include anticoagulants or aspirin. Anticoagulants are more effective in preventing recurrent strokes if AF is present, offering an 80% risk reduction compared to aspirin's 20%. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6-12 months. Despite the clinical rationale for using anticoagulants during this search period, their benefit-risk ratio compared to aspirin has not been fully evaluated.

Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction（ELASTIC）

This study evaluates whether early administration of low-dose aspirin (100mg) at 2 hours post-intravenous thrombolysis, compared to the standard timing of 24 hours, improves functional outcomes in patients with acute ischemic stroke. Intravenous thrombolysis is effective for very early treatment of acute ischemic stroke. However, current guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis to avoid symptomatic intracranial hemorrhage (SICH), a recommendation not based on prospective clinical studies. Early re-occlusion of recanalized arteries due to platelet aggregation occurs in 14-34% of cases and is associated with poor prognosis. The average incidence of SICH is 2.4%, with fatal SICH occurring in only 0.28%. Thus, the impact of re-occlusion on poor prognosis may outweigh the risk of SICH. In this prospective, randomized, open-label trial with blinded endpoint evaluation, participants are assigned to receive aspirin 100mg either at 2 hours (early group) or at 24 hours (standard group) after thrombolysis. The primary outcome is the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 3 months. Safety outcomes include the incidence of SICH and all-cause mortality at 3 months. This study will provide clinical evidence regarding the optimal timing for initiating antiplatelet therapy after thrombolysis in acute ischemic stroke.

Safely Quenching Complement in Stroke Survivors

This study will include adults (ages 18-80) who have had a stroke caused by a large blood clot blocking blood flow in the brain. All patients in the study must have already had a treatment called a thrombectomy, where doctors remove the clot to help blood flow return to the brain. The goal of this study is to test the safety of a drug called EMPAVELI (pegcetacoplan). This drug is meant to lower swelling and inflammation that can happen after blood flow returns. The hope is that it may help protect the brain from more damage and improve recovery. People in the study will get three doses of EMPAVELI through an EMPAVELI-designed pump 0-3 hours post thrombectomy surgery and 24 and 48 hours after the initial dose. Doctors will check them with exams, blood tests, brain scans, and other tests while they are there. Patients will also have follow-up visits at 30 and 90 days to see how they are doing, per the usual standard of care. This research is important because, even with current stroke treatments, many patients still have problems like disability. If this drug is found to be safe, it could lead to better treatments to protect the brain and help people recover more fully after a stroke.

Human Umbilical Cord Mesenchymal Stem Cell Therapy (19#iSCLife®-CI) for Cerebral Infarction Patients in Convalescent Period.

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction

The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).

The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.

Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction

The aim of this study is to determine the efficacy and safety of binaural synchronous vagus nerve regulation in the treatment of patients with sensory and motor dysfunction after cerebral infarction through a randomized controlled clinical study, and to provide high-quality evidence support for binaural synchronous vagus nerve regulation in the treatment of cerebral infarction.

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.

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

Observation of the Therapeutic Effect of Fire Needle on Upper Limb Function in Stroke Patients

Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with 35 patients in each group. Patients in the extensor treatment group were treated with extensor group moxibustion, patients in the flexor treatment group were treated with flexor group moxibustion, and patients in the control group were treated with conventional moxibustion. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before and after treatment, and determine the clinical efficacy. Result: Moxibustion therapy with moxibustion is helpful in improving upper limb dysfunction in stroke patients, safe and reliable, and worthy of application. The efficacy of needling the flexor muscle group with moxibustion is better than that of needling the extensor muscle group and conventional acupuncture, providing certain evidence and guidance for the selection of moxibustion sites in clinical practice.

Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are： 1. Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis? 2. What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works. Participants will: 1. Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation 2. Visit the clinic or call for follow-up at 90 days of onset

Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis

IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.

A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke

BCAIS-I is a single-center, randomized, double-blind, dose-response controlled clinical Trial, to preliminarily explore the efficacy of two different maintenance doses of bevifibatide citrate injection in improving 90-day neurological outcomes and the incidence of symptomatic intracranial hemorrhage in patients with acute ischemic stroke without large or medium-sized vessel occlusion, aiming to identify a dosing regimen that maintains therapeutic efficacy while minimizing the rates of symptomatic intracranial hemorrhage and serious adverse events, thereby providing dosing evidence for future large-scale randomized controlled trials.