Multimodal Neurofunctional Profiling in Stroke

N/AActive Not RecruitingNCT07411573

Peking Union Medical College Hospital1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Stroke

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged ≥18 years at the time of enrollment. * Clinical and/or neuroimaging-confirmed diagnosis of stroke (ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage, as applicable). * Ability to undergo non-invasive neurofunctional assessments (e.g., EEG and/or fNIRS). * Ability to complete standardized neurological and functional assessments, including the Fugl-Meyer Assessment (FMA), or availability of a legally authorized representative to provide consent and facilitate participation. * Provision of written informed consent by the participant or legally authorized representative. Exclusion Criteria: * Pre-existing neurological conditions resulting in severe baseline motor disability that would confound FMA-based outcome assessment (e.g., prior stroke with significant residual deficits, advanced neurodegenerative disorders). * Contraindications to required non-invasive assessments (e.g., scalp conditions or implanted electronic devices incompatible with EEG/fNIRS, where applicable). * Inability to comply with study procedures or follow-up schedule, as determined by the investigators. * Participation in another interventional clinical trial that, in the opinion of the investigators, could interfere with the outcomes of this observational study.

Locations (1)

Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 3 to 6 months after stroke onset

Secondary Outcomes

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.

Time frame: 3, 6, and 12 months after onset

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.

Time frame: 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.

Time frame: After onset, up to 30 days

Data from ClinicalTrials.gov

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