Multimodal Neurofunctional Profiling in Stroke

NCT07411573 | Active Not Recruiting DMC

• 2 other identifiers: I-25PJ29902025-PUMCH-D-004
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Neurofunctional Profiling; Clinical Outcomes; Neurological Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

CN (1)