Clinical trials

The goal of this clinical trial is to learn if personalized, multimodal imaging-guided, EEG-based closed-loop Temporal Interference Brain Stimulation (TIBS) can improve memory function in individuals with preclinical Alzheimer's Disease (AD). The main questions it aims to answer are: 1. Does personalized TIBS lead to significant changes in functional connectivity strength of hippocampal-cortical networks at the end of the 2-week intervention compared to baseline? 2. What are the short-term (end of 2-week intervention) and medium-to-long-term (4 weeks and 12 weeks post-intervention) effects of personalized TIBS on episodic and working memory, as well as other cognitive domains in preclinical AD? 3. How does personalized TIBS modulate brain activity and connectivity, as measured by EEG power spectra and functional MRI (fMRI) functional connectivity, in preclinical AD? 4. What is the safety profile of personalized TIBS in this population? Researchers will compare participants receiving active personalized TIBS to participants receiving sham (inactive) stimulation to see if TIBS effectively improves memory function and induces neural plasticity. Participants will: 1. Undergo initial screening including neuropsychological assessments and blood p-tau217 testing to identify preclinical AD. 2. Receive either active personalized TIBS or sham stimulation daily for 40 minutes, 6 days a week, for 2 weeks. 3. Have individualized TIBS parameters (e.g., target localization, intensity) determined using baseline structural MRI and DTI. 4. Undergo real-time high-density EEG monitoring during daily stimulation sessions to enable closed-loop adjustment of stimulation parameters. 5. Participate in follow-up assessments at the end of the 2-week intervention, and at 4 weeks and 12 weeks post-intervention. 6. Receive multimodal imaging (sMRI, rs-fMRI, task-fMRI, DTI) and blood biomarker assessments at various time points. 7. Receive Aβ-PET and tau-PET scans, along with comprehensive neuropsychological assessments, at the 12-week follow-up. 8. Have their safety continuously monitored throughout the study.

This study will evaluate whether an artificial intelligence (AI)-driven dynamic health management strategy can help prevent ischemic stroke in adults at high risk of stroke. Participants will be identified through community-based screening in Beijing using the AI-ExpoStroke model together with established stroke risk factors. Communities will be randomly assigned to either an AI-driven health management group or a usual community-based health management group. Participants in the AI-driven group will receive continuous health management supported by a digital platform, mobile applications or WeChat-based tools, wearable-device data when available, personalized health guidance, and remote support from community health care providers. Participants in the usual-care group will receive routine community health services, including health examinations, health education, chronic disease follow-up, and medication guidance. Participants will be followed for 36 months. The main goal is to determine whether AI-driven health management reduces the occurrence of first-ever ischemic stroke. The study will also evaluate transient ischemic attacks, stroke-related disability, mortality, control of major vascular risk factors, adherence to health management, and health economic outcomes.

This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.

Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management. Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders. Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed. Anticipated Results: the investigators hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases. Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.

TIME-ICH (TrIal of early Minimally Invasive catheter Evacuation with thrombolysis in IntraCerebral Hemorrhage) is a multicenter, randomized, adaptive clinical trial comparing best medical management to early minimally invasive surgery with thrombolysis (eMIST) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of intracranial aneurysms. Adults with an intracranial aneurysm who are scheduled to undergo coil embolization will be enrolled and followed for approximately 12 months. The study will not assign participants to a treatment strategy. All treatment decisions will be made by the treating physicians according to routine clinical practice. Participants will be analyzed according to whether microcatheter shaping is performed based on the physician's experience alone or with assistance from an intelligent microcatheter shaping simulation technology. The study will evaluate major adverse events within 12 months, immediate aneurysm occlusion after the procedure, clinical and quality-of-life outcomes, follow-up imaging findings, serious adverse events, repeat treatment or rehospitalization, microcatheter delivery performance, and health care resource use. At least 1,438 participants are planned to be enrolled.

The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus

This is a single-center, prospective, observational cohort study that plans to consecutively enroll 400 patients with acute ischemic stroke from July 2026 to July 2029. The study will not interfere with acute-phase treatment decisions; information on reperfusion and non-reperfusion treatment will be recorded according to the actual clinical care pathway. After completion of necessary acute treatment, once vital signs are stable and clinical conditions permit, all participants will undergo one resting-state EEG recording as early as possible, within 7 days after symptom onset or the last-known-well time. For patients receiving reperfusion therapy, EEG will be acquired after completion of the reperfusion procedure, and intervals such as onset-to-reperfusion initiation and completion of reperfusion-to-EEG acquisition will be recorded. For patients not receiving reperfusion therapy, EEG will be acquired after the stroke diagnosis is established, routine treatment has been initiated, and the clinical condition is stable; onset-to-admission and onset-to-EEG acquisition intervals will be recorded. EEG features will be extracted and combined with clinical and imaging variables to construct prognostic models. The primary outcome is functional outcome at 3 months after onset, dichotomized as mRS 0-2 versus 3-6. The primary analysis will evaluate the incremental predictive value of EEG phenotypes for poor 3-month functional outcome beyond a conventional clinical-imaging model. Secondary analyses will include validation of 6-month outcomes, functional and cognitive scale outcomes, and differences in EEG phenotypes across treatment pathways.

This multicenter retrospective registry study evaluates the safety and effectiveness of endovascular therapy versus medical therapy for acute large-core basilar artery occlusion. It also investigates clinical, imaging, and laboratory factors associated with functional outcomes and mortality. Patients are grouped according to the treatment received in routine clinical practice.

The goal of this clinical trial is to learn whether expansile duraplasty can improve neurological recovery in adult patients with acute severe traumatic spinal cord injury, as well as evaluate the safety of this surgical strategy. The main questions the study aims to answer are: 1. Does expansile duraplasty lead to superior motor function recovery in patients with acute severe traumatic spinal cord injury? 2. How safe is the use of expansile duraplasty in people with acute traumatic SCI? Researchers will compare neurological function, quality of life and all safety indicators who receive expansile duraplasty to that of participants who do not receive expansile duraplasty, to determine whether the additional expansile duraplasty provides better recovery benefits for patients with traumatic spinal cord injury. Participants will be randomly assigned to one of two groups: the laminectomy combined with expansile duraplasty group and the laminectomy-only group. All participants will complete the following procedures: 1. Receive standardized spinal surgery ; 2. Provide blood and cerebrospinal fluid samples during hospitalization; 3. Undergo spinal computed tomography (CT) and magnetic resonance imaging (MRI) scans at baseline (pre-operation), discharge, 3 months, 6 months and 12 months after surgery; 4. Complete standardized neurological assessments at 3, 6 and 12 months postoperatively, including ASIA motor and sensory scores, Walking Index for Spinal Cord Injury II (WISCI II), and Spinal Cord Independence Measure III (SCIM III); 5. Fill out questionnaires at each follow-up visit, including the 36-Item Short Form Health Survey (SF-36); 6. Be continuously monitored for all adverse events and surgical complications throughout the 12-month follow-up period.

Brief Summary: This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant. A total of 156 participants will be enrolled. The study consists of a 1-week baseline phase and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily while BZRAs are gradually tapered and discontinued based on individual patient response. The primary outcome is the proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant and no withdrawal due to worsening insomnia or adverse events. Secondary outcomes include changes in Insomnia Severity Index (ISI) scores and patient-reported sleep outcomes. This study aims to provide real-world evidence for the safe and effective transition from BZRAs to daridorexant in clinical practice.

This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.

The purpose of this clinical trial is to investigate the effect of multimodal brain monitoring under general anesthesia on postoperative outcomes in elderly patients undergoing abdominal surgery.The research hypothesis is that multimodal brain monitoring under general anesthesia can reduce the incidence of postoperative composite complications and improve postoperative outcomes in elderly patients undergoing major abdominal surgery. Eligible patients will be randomly assigned in a 1:1 ratio to the Multimodal Brain Monitoring under General Anesthesia Group (MBMGA group) and the Bispectral Index Monitoring under General Anesthesia Group (BIS group). The primary outcome is the postoperative composite complication rate . Secondary outcomes include intraoperative hyperglycemia, adverse events during anesthesia induction and maintanance, changes in blood pressure and heart rate, intraoperative hypotension, the dosage of perioperative anesthetics and vasoactive drugs, changes in serum cortisol, cardiac troponin I, blood creatinine (Cr) level, extubation time and awake time, the rate of transferring to ICU or AICU, The time to first use analgesia pump and the cumulative dose of postoperative oxycodone, systemic complications, hospitalization time, first exhaust time , first oral intake time, rate of second surgery and mortality within 30 days postoperatively. Participants will: 1. Undergo routine preoperative fasting for 6-8 hours; 2. Prior to anesthesia induction, cooperate with the establishment of intravenous access, arterial catheterization, monitoring of physiological parameters, blood sample collection, and receive fluid preloading; 3. During surgery, for patients in the MBMGA group , propofol and remifentanyl will be adjusted according to multimodal brain monitoring indices (WLi and PTi), while for patients in the BIS group, only propofol will be adjusted based on bispectral index and remifentanyl will be adjusted according to anesthesiologists' experience; simultaneously, vital signs, including respiration, body temperature, fluid therapy, blood pressure, and heart rate regulation, will be monitored and managed. 4. After surgery, endotracheal tubes will be removed once extubation criteria are met, and patients will be transferred to the PACU, where they will receive routine monitoring and will be discharged from the PACU upon meeting corresponding scoring criteria; 5. Participates in follow-ups on the day of surgery and for 1-30 days postoperatively, during which investigators will record the primary outcome and secondary outcomes.

The incidence of postoperative anxiety in surgery ranges from 4.1% to 79.6% , and among patients undergoing intraspinal tumor resection surgery, the incidence of postoperative anxiety is as high as 46.7%.Adverse effects induced by anxiety include insomnia, exacerbated pain, impaired wound healing and immune function, increased risk of adverse cardiovascular events, and postoperative cognitive dysfunction. These may lead to postoperative depression and chronic pain, significantly delaying patient recovery. The goal of this study is to investigate the effects of intraoperative transcranial alternating current stimulation on postoperative anxiety in adult patients undergoing intraspinal tumor resection. It will also evaluate the safety of the transcranial alternating current stimulation. This study will enroll adult patients undergoing elective intraspinal tumor resection surgery. The study will compare the transcranial alternating current stimulation with a sham stimulation to see whether the intervention can reduce the incidence of postoperative anxiety. The trial will also compare the anxiety scores, the incidence of delirium, pain scores, frial scores, sleep quality scores, recovery quality scores and adverse events between intervention and control groups. We also plan to compare the electroencephalography parameters and serum level of substance P to investigate the potential mechanism.

This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in drug-resistant epilepsy patients aged 6-60.

This study will determine the optimal timing for Anrikefon administration. It will also assess the quality of patient recovery. Laparoscopic cholecystectomy (LC) is a routine surgical procedure. However, the incidence of acute visceral and incision pain is high, reaching 50% to 70%. This pain significantly impairs patient recovery. Anrikefon is novel peripherally restricted κ-opioid receptor agonist. It has very low brain penetration. This property reduces central nervous system side effects and respiratory depression. Preventive analgesia blocks the transmission of nociceptive stimuli to the central nervous system. It reduces postoperative pain sensitization and intensity. Currently, research on Anrikefon for preventive analgesia in LC patients is limited. It impacts on the recovery process is not yet fully understood. This study will compare drug administration before anesthesia induction with intra-operative administration. Participants will be assigned to one of two groups with equal probability using computer-generated random numbers. Patients in the Preventive Analgesia group will receive Anrikefon injection 15 minutes before anesthesia induction. Bridging Analgesia group is the control group. Patients in this group will receive Anrikefon immediately after the gallbladder is detached from the liver. Both groups will receive the identical drug dosage of 1 μg/kg. Both treatment groups will receive identical care beyond the time of Anrikefon administration. All patients will undergo standardized anesthesia management. Parecoxib sodium 40 mg will be injected for rescue analgesia if NRS score \> 4. We will analyze the primary, secondary, and exploratory outcome measures after surgery, aiming to explore the optimal timing of Anrikefon and its impact on the patient's recovery process.

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

This is a single-center, investigator-initiated, prospective observational case-control study. Patients with intracerebral hemorrhage and healthy controls will be enrolled at Xuanwu Hospital, Capital Medical University. Peripheral venous blood samples will be collected for measurement of CIRP, Cathepsin B, and related inflammatory biomarkers. Clinical and imaging data will also be collected in the intracerebral hemorrhage group. The study aims to compare biomarker levels between patients with intracerebral hemorrhage and healthy controls and to explore the potential role of these biomarkers in neuroinflammation after intracerebral hemorrhage. No investigational treatment will be administered.

Stroke remains a major global health burden, with acute ischemic stroke (AIS) accounting for more than 65% of all cases. Endovascular thrombectomy (EVT) has been established as a standard treatment for large vessel occlusion (LVO) stroke; however, "futile recanalization" remains common, with many patients failing to achieve favorable functional outcomes despite successful vessel reperfusion. Increasing evidence indicates that neutrophils and neutrophil extracellular traps (NETs) play important roles in post-reperfusion inflammation, thrombosis, and microcirculatory dysfunction, which may contribute to thrombolysis resistance and poor prognosis. Neutrophil elastase (NE), a key component associated with NETs, may further aggravate vascular injury and thrombus formation. Sivelestat Sodium is a selective NE inhibitor that has demonstrated anti-inflammatory and organ-protective effects in patients with acute respiratory distress syndrome and in experimental models of cerebral ischemia. It may help preserve blood-brain barrier integrity, reduce brain edema, and improve neurological outcomes. Based on these findings, this study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sivelestat sodium as an adjunct to EVT in patients with acute anterior circulation large-vessel occlusive stroke within 24 hours of onset. The results of this study are expected to provide further clinical evidence for anti-inflammatory adjunctive treatment strategies aimed at reducing futile recanalization and improving functional outcomes in AIS.

Stroke is a leading cause of global mortality and morbidity, with acute ischemic stroke (AIS) accounting for approximately 65.3% of cases and resulting in roughly 3.4 million new cases annually in China. While endovascular thrombectomy (EVT) is the recommended first-line therapy for large vessel occlusion (LVO), achieving 80-90% recanalization, fewer than 50% of patients reach functional independence (mRS 0-2) due to "futile recanalization" caused by mechanisms like no-reflow and reperfusion injury. Monosialotetrahexosylganglioside (GM1) is a unique glycosphingolipid that crosses the blood-brain barrier to provide neuroprotection by suppressing oxidative stress, excitotoxicity, and apoptosis while promoting neurogenesis. Although Phase III trials like the FOCUS study confirmed GM1's safety and efficacy in AIS populations, its benefit specifically for patients undergoing mechanical thrombectomy remains unkown. Therefore, the IAT-GIANT study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of adjunctive GM1 in improving 90-day functional outcomes for AIS-LVO patients treated with EVT.

MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.

The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are: Does adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone? Is the treatment combination safe for participants? Researchers will compare two groups: Group 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule. Group 2 (Control): Standard treatment alone. Participants in this study will: Be adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI). Be randomly assigned to one of the two treatment groups. Take their assigned treatment for 6 months. Attend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.

We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.

Alzheimer's disease (AD) presents a significant socio-economic challenge globally, with China experiencing a notable rise in its prevalence. This study addresses critical gaps in understanding AD's economic burden and quality of life (QoL) impacts on patients and caregivers in Mainland China.

This multicenter registry study aims to clarify the incidence trends of intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China, evaluate current treatment patterns, and establish a nationwide multicenter retrospective and prospective database. The study is designed as a multicenter retrospective and prospective observational study involving more than 60 core hospitals across seven major geographic regions of China. The retrospective phase will include patients diagnosed between February 28, 2015 and February 28, 2025, while the prospective phase will enroll patients from March 1, 2025 to March 1, 2030. Eligible participants are patients diagnosed with IDAVF or SDAVF by digital subtraction angiography (DSA). The study will analyze disease incidence and temporal trends, collect baseline demographic and clinical characteristics, and evaluate treatment outcomes including obliteration rate, recurrence rate, and clinical prognosis. The crude incidence rate per 100,000 person-years during the study period will also be calculated based on Chinese census population data. The primary endpoint is the improvement rate in modified Rankin Scale (mRS) score at 6 months after treatment. Secondary endpoints include obliteration and recurrence rates on imaging follow-up at 6 months and improvement in mRS score at 12 months after treatment. Statistical analyses will be performed using SAS 9.4 software, including descriptive analyses as well as univariate and multivariate regression analyses to identify factors associated with clinical outcomes and prognosis.