A Prospective Observational Cohort Study of Multimodal Neurofunctional Profiling in Patients With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Motor functional outcome measured by the Fugl-Meyer Assessment (FMA)
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Outcomes
Primary Outcomes
Motor functional outcome measured by the Fugl-Meyer Assessment (FMA)
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.
Secondary Outcomes
- Modified Rankin Scale (mRS) score for functional outcome(3, 6, and 12 months after onset)
- Brain-Heart Interaction-Related Complications(After onset, up to 30 days)
- Incidence of delayed cerebral ischemia (DCI)(After onset, up to 30 days)