Clinical trials

The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. The main questions it aims to answer are: * Are there differences in the risk of another stroke between people receiving antiplatelet treatment and those receiving anticoagulant treatment? * Are there differences in the risk of bleeding between the treatment groups? * Which clinical characteristics, imaging findings, cancer-related factors, and blood test results are associated with treatment outcomes? Participants will: * Receive antiplatelet treatment, anticoagulant treatment, or a combination of both, as selected by their treating physicians during routine clinical care. * Provide clinical information and blood samples for the study. * Complete follow-up assessments approximately 30, 90, 180, and 360 days after the stroke. Researchers will compare recurrent stroke, bleeding, other blood clot-related events, functional recovery, and survival among participants receiving different antithrombotic treatments. The study will not assign or change participants' treatments.

The primary objective of this research is to study direct electrical stimulation of central autonomic network for blood pressure control.

This study used a multicenter, double-blind, randomized controlled design. The trial protocol was jointly designed by the principal investigator and an executive committee composed of experts in functional neurosurgery, cerebrovascular disease, and rehabilitation medicine. The study enrolled patients in the subacute phase (3-6 months) after ischemic stroke with upper limb motor impairment. All patients were implanted with a vagus nerve stimulation (VNS) device and randomly assigned to an active VNS (0.8 mA) group combined with upper limb rehabilitation or a control VNS (0.0 mA) group. This study used the FMA-UE score, WMFT score, and other measures to assess changes in impairment severity. The primary endpoint was the difference in FMA-UE score between the active VNS group and the control group at the end of 6 weeks of hospital treatment. Secondary endpoints included changes from baseline in FMA-UE score and WMFT score at 90 days, among others. This study evaluates the safety and efficacy of vagus nerve stimulation for improving upper limb motor function in patients in the subacute phase after stroke, ultimately providing clinical evidence for the diagnosis and treatment of this patient population.

This randomized controlled trial aims to evaluate whether a proximal-distal dual cerebral protection strategy can reduce the occurrence of new cerebral ischemic lesions compared with a single cerebral protection strategy in patients undergoing carotid artery stenting. Eligible participants will be randomly assigned to receive either dual cerebral protection using proximal flow control combined with a distal embolic protection device or conventional single cerebral protection. Brain magnetic resonance imaging will be performed after the procedure to assess new ischemic lesions. The study will also evaluate peri-procedural neurological events and other safety and efficacy outcomes.

This is a prospective cohort study of patients with cognitive impairment mood disorders and behavioral disorders. Comprehensive baseline and longitudinal follow-up assessments include clinical and epidemiological data, cognitive function and neuropsychological assessments, laboratory measurements, and neuroimaging data, along with the collection of blood, urine, feces, and cerebrospinal fluid for biobanking. Multi-omics, multidimensional cognitive assessments, and multimodal neuroimaging data are integrated using statistical analyses to establish a comprehensive clinical database and biobank. The study aims to identify risk factors, elucidate mechanisms underlying the comorbidity of cognitive impairment and mood disorders, discover multimodal biomarkers, and improve early screening, risk prediction, and diagnosis

The entire clinical study will be conducted strictly following the following procedure: 1) Informed Consent If you decide to participate in this trial, we will first ensure that you fully understand the research purpose, procedure, possible benefits, and risks before conducting trial-related activities, and you will voluntarily sign the informed consent form. If a new version of the informed consent form is generated during the trial, you will also need to sign it again. 2\) Screening: After signing this informed consent form, the first step is screening. The purpose of screening is to determine whether you meet the requirements for participating in this clinical trial. We will collect your medical history, fill out general information, conduct a physical examination, measure vital signs, height, and weight, and collect blood routine, liver and kidney function tests (which should at least include the following indicators: alanine aminotransferase, aspartate aminotransferase, γ-glutamyltranspeptidase, creatine kinase, creatinine, urea, uric acid, albumin, glucose, low-density lipoprotein, total cholesterol, triglycerides, potassium, sodium, calcium). We will also complete professional assessments related to sarcopenia and frailty, including the Timed Up and Go (TUG) test, calf circumference measurement, grip strength test, Bioelectrical Impedance Analysis-Skeletal Muscle Index (BIA-SMI), 4-meter daily walking speed test, Sarcopenia Assessment Rating Scale (SARC-F), and Fried frailty phenotype assessment. After the aforementioned procedures are completed, the research doctor will determine whether you can continue participating in the clinical trial. If you are unable to continue participating in the trial, the research doctor will also explain the reasons to you. 3\) Randomization: According to the randomization rules, you will be randomly assigned (similar to flipping a coin) to either the intervention group or the control group, with a 50% probability for each group. Throughout the entire study period, neither you nor the researchers who are conducting the study will be informed of your group assignment, and the blinding will be maintained until the end of the study. 4\) After being enrolled in the study intervention, you are required to attend treatment at the designated location according to the appointment time. Regardless of which group you are assigned to, the treatment site, duration, and procedure are completely identical. If you are assigned to the intervention group, the equipment will output standard pulsed electromagnetic fields for treatment; if you are assigned to the control group, the equipment will only simulate sound, vibration, and the operation process without generating magnetic field output, which is used for comparing the study effects. During each treatment session, you only need to sit quietly and cooperate, without any additional exercise. 5\) Follow-up assessment time and content: You are required to cooperate with the researchers to complete assessments at two time points: before the first treatment (baseline) and 2-5 days after completing 24 treatments. For each assessment, you need to cooperate with the researchers to complete the Timed Up and Go (TUG) test, calf circumference measurement, BIA-SMI, grip strength test, sarcopenia screening scale (SARC-F), 4-meter usual walking speed, Fried frailty phenotype assessment, Berg Balance Scale (BBS), single-leg standing time, five sit-to-stand tests (5STS), pain score (VAS), European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L), Short Physical Performance Battery (SPPB), intrinsic capacity assessment (IC), Activities of Daily Living (ADL) scale, Mini-Nutrient Assessment (MNA), Geriatric Depression Scale-Short Form (GDS-SF), Mini-Mental State Examination (MMSE), and Montreal Cognitive Assessment (MoCA). The tests you have completed during the screening period will not be repeated during the baseline assessment. Additionally, the following laboratory tests are required for each assessment: follistatin, myostatin, IGF-1, interleukin-6 (IL-6), TNF-α, growth differentiation factor-15 (GDF-15), peripheral blood free mitochondrial DNA content, clusterin C-terminal fragment-22 (CAF-22), and metabolomics. These tests require approximately 15ml of venous blood (3-5 tubes of blood). Throughout the study, the researchers will monitor and record any adverse events and safety-related situations. 6\) Upon completion of all 24 treatments and the final assessment, you will have completed your participation in this study, and will then return to your regular health management and clinical diagnosis and treatment.

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.

To compare the safety and efficacy of carotid revascularization performed within 48 hours versus after 14 days in patients with symptomatic carotid stenosis accompanied with MRI-confirmed acute infarction (high signal on diffusion-weighted imaging accompanied by low apparent diffusion coefficient signal) in the responsible vascular territory.

Posterior circulation stroke accounts for 20% of all ischemic stroke. Approximately one quarter of posterior circulation strokes are due to stenosis in the vertebral artery and basilar artery. Two previous randomized controlled trials focusing on vertebral artery stenting, the Vertebral Artery Stenting Trial (VAST) and the Vertebral Artery Ischaemia Stenting Trial (VIST) were underpowered because they failed to reach target recruitment, and both the trials found no difference in risk of the primary outcome between the stenting group and medical group. The drug-eluting stenting versus medical therapy alone for patients with extracranial vertebral artery stenosis (VISTA) trial, is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit patients with 3 months stroke or TIA caused by 70-99% stenosis of extracranial vertebral artery (V1-2 segments). Only high-volume center with a proven track record will enroll patients. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus stenting. Primary outcome is a composite of any fatal or non-fatal stroke within 30 days after randomization, or ischemic stroke in the territory of the target artery beyond 30 days to 1 year. The VISTA trial will be conducted in 30 sites in China and aims to have a sample size of 472 subjects (stenting, 236; medical treatment, 236). Recruitment is expected to be finished by Sep, 2025. Patients will be followed for 1 year at first stage. Long-term follow-ups till 3 years or longer is also preplanned. The first stage of the trial is scheduled to complete in 2027.

To evaluate the safety and efficacy of the Medeliver® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

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.

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.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of efavirenz in patients with Creutzfeldt-Jakob disease (CJD). A total of 246 eligible participants will be enrolled across 21 study centers nationwide. Participants will be randomly assigned in a 1:1 ratio to receive either efavirenz or placebo. Participants in the efavirenz group will receive 200 mg once daily at bedtime for the first week, followed by an increased dose of 400 mg once daily thereafter. Participants in the placebo group will receive matching placebo tablets using the same dosing schedule. Treatment will be administered under double-blind conditions and will continue until death or study completion. During the study, all participants will receive monthly telephone follow-up assessments starting from treatment initiation to evaluate long-term efficacy and safety, continuing until death or study termination. The primary objective of the study is to determine whether efavirenz can prolong survival in patients with CJD. The primary endpoint is median survival time from randomization to death. Secondary endpoints include assessment of the effect of efavirenz on the rate of functional decline and treatment tolerability. Adverse events (AEs) and serious adverse events (SAEs) will be recorded and evaluated for frequency, severity, outcomes, and their relationship to the study drug. Key inclusion criteria include adults aged 18 to 80 years of either sex with a baseline MRC-Prion Disease Rating Scale (MRC-PDRS) score greater than 10 and the availability of a reliable caregiver to support study participation. Key exclusion criteria include the presence of other serious or life-threatening illnesses, use of medications contraindicated with efavirenz that cannot be adjusted, and pregnancy or breastfeeding. Written informed consent will be obtained from all participants or their legally authorized representatives prior to enrollment.

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 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.

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.

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.