Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT07411573
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 active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Beijing, Beijing Municipality, 100730, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 to 6 months after stroke onset
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.
Time frame: 3, 6, and 12 months after onset
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.
Time frame: After onset, up to 30 days
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.
Time frame: After onset, up to 30 days
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.
Peking Union Medical College Hospital
Other
A Prospective Observational Cohort Study of Multimodal Neurofunctional Profiling in Patients With Stroke
Acronym: MNPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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