Multimodal Neurofunctional Profiling in Stroke (MNPS)

A Prospective Observational Cohort Study of Multimodal Neurofunctional Profiling in Patients With Stroke

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke

Detailed Description

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 (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Tiantan Hospital; West China Hospital; Peking University International Hospital; Beijing Hospital; Henan Provincial People's Hospital; The First Affiliated Hospital of Shanxi Medical University; Cangzhou Central Hospital; Huashan Hospital North, Fudan University; Jiujiang No.1 People's Hospital; Zhangzhou Municipal Hospital of Fujian Province

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Clinical Outcomes; Neurological Function; Neurofunctional Profiling
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: I-25PJ2990; 2025-PUMCH-D-004 (Other Grant/Funding Number: National High Level Hospital Clinical Research Funding)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No