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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-PUMCH-D-004 | Other Grant/Funding Number | National High Level Hospital Clinical Research Funding |
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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Peking University International Hospital | OTHER |
| Zhangzhou Municipal Hospital of Fujian Province | OTHER |
| The First Affiliated Hospital of Shanxi Medical University |
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This prospective, observational cohort study aims to characterize multimodal neurofunctional profiles in patients with stroke. By integrating neurophysiological signals, neuroimaging data, clinical assessments, and biological samples, the study seeks to delineate patterns of brain function and their associations with clinical outcomes. The findings are intended to support improved risk stratification, phenotypic classification, and a deeper understanding of the neurobiological mechanisms underlying stroke-related functional impairment and recovery.
This study is designed as a prospective, observational cohort study to systematically characterize multimodal neurofunctional profiles in patients diagnosed with stroke based on standardized clinical and neuroimaging criteria. Participants will be consecutively enrolled at participating centers and followed longitudinally in accordance with a predefined study protocol.
Multimodal assessments will be conducted at baseline within predefined time windows after enrollment and repeated at scheduled follow-up time points. Data collection will include neurophysiological measurements, such as electroencephalography and functional near-infrared spectroscopy; structural and functional neuroimaging, including magnetic resonance imaging and/or computed tomography; standardized neurological and functional assessments using validated scales, such as the modified Rankin Scale (mRS); and the collection of peripheral biological samples, including blood and/or urine, for exploratory biomarker and multi-omics analyses.
Relevant clinical variables will be systematically recorded, including demographic characteristics, vascular risk factors, stroke subtype and etiology, acute management strategies, and in-hospital complications. Functional outcomes will be evaluated at prespecified follow-up time points to assess both short- and long-term neurological recovery, neurological deterioration, and the occurrence of major adverse events.
The overarching objective of this cohort is to establish a comprehensive, multimodal dataset that supports the identification of neurofunctional phenotypes, facilitates exploratory biomarker discovery, and provides a robust foundation for future hypothesis-driven and interventional studies in stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke Neurofunctional Cohort | This prospective observational cohort includes adult patients with imaging-confirmed stroke admitted within predefined time windows after symptom onset or hospital presentation. Participants undergo multimodal neurofunctional assessments, including non-invasive neurophysiological monitoring (such as EEG and/or fNIRS), standardized clinical and functional evaluations, and the collection of peripheral biological samples. No experimental intervention is assigned, and all patients receive standard-of-care treatment as determined by the treating clinicians. The cohort is followed longitudinally to characterize dynamic neurofunctional profiles and to examine their associations with clinical outcomes and major adverse events. |
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| Measure | Description | Time Frame |
|---|---|---|
| Motor functional outcome measured by the Fugl-Meyer Assessment (FMA) | Motor function will be assessed using the Fugl-Meyer Assessment (FMA), a validated, stroke-specific, performancebased scale evaluating motor impairment of the upper and lower extremities. The primary endpoint will be the total FMA motor score, with higher scores indicating better motor function. | 3 to 6 months after stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) score for functional outcome | Functional outcome will be evaluated using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death). Higher scores indicate greater disability. The distribution of mRS scores will be analyzed at predefined follow up time points. | 3, 6, and 12 months after onset |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients with clinically and/or neuroimaging-confirmed stroke, including ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage, who are enrolled within predefined time windows after symptom onset or hospital presentation. Participants are consecutively recruited at participating centers and followed longitudinally according to a standardized study protocol. The cohort includes individuals capable of undergoing multimodal neurofunctional assessments, standardized clinical and functional evaluations, and peripheral biological sample collection, where applicable. All participants receive standard-of-care clinical management as determined by the treating clinicians, and no experimental interventions are assigned as part of this observational study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Henan Provincial People's Hospital | OTHER |
| Huashan Hospital | OTHER |
| Cangzhou Central Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Jiujiang No.1 People's Hospital | OTHER |
| West China Hospital | OTHER |
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| Brain-Heart Interaction-Related Complications |
Brain-heart interaction-related complications are defined as acute cardiac dysfunction secondary to acute brain injury, manifested by newly developed electrocardiographic abnormalities (including ST-T changes, QT interval prolongation, and arrhythmias), elevation of myocardial injury biomarkers (such as cardiac troponin, CK-MB, BNP, or NT-proBNP), and/or echocardiographic evidence of left ventricular systolic or diastolic dysfunction. These abnormalities typically occur within 72 hours after disease onset and require exclusion of pre-existing coronary artery disease or primary cardiomyopathy. |
| After onset, up to 30 days |
| Incidence of delayed cerebral ischemia (DCI) | DCI is defined as new focal neurological deficits or global neurological deterioration (a decrease of ≥2 points on the Glasgow Coma Scale) lasting more than 2 hours, after excluding intracranial hemorrhage, hydrocephalus, seizures, metabolic derangements, and infection, with or without radiological evidence of cerebral vasospasm. | After onset, up to 30 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |