StrokeMNPSNCT07411573
Multimodal Neurofunctional Profiling in Stroke
An observational study of Stroke, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Stroke, Neurofunctional Profiling, Clinical Outcomes, Neurological Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 6 months after stroke onset
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: After onset, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Jan 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University International Hospital, Zhangzhou Municipal Hospital of Fujian Province, The First Affiliated Hospital of Shanxi Medical University, Henan Provincial People's Hospital, Huashan Hospital, Cangzhou Central Hospital, Beijing Hospital, Jiujiang No.1 People's Hospital, West China Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411573
- Sponsor's protocol ID
- I-25PJ2990
- Other IDs
- 2025-PUMCH-D-004
- Acronym
- MNPS
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Multimodal Neurofunctional Profiling in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07411573
- Acronym / sponsor ID
- MNPS / I-25PJ2990
- Conditions
- Stroke
- Keywords
- Stroke, Neurofunctional Profiling, Clinical Outcomes, Neurological Function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University International Hospital, Zhangzhou Municipal Hospital of Fujian Province, The First Affiliated Hospital of Shanxi Medical University, Henan Provincial People's Hospital, Huashan Hospital, Cangzhou Central Hospital, Beijing Hospital, Jiujiang No.1 People's Hospital, West China Hospital
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Modified Rankin Scale (mRS) score for functional outcome
Time frame: 3, 6, and 12 months after onset
Brain-Heart Interaction-Related Complications
Time frame: After onset, up to 30 days
Incidence of delayed cerebral ischemia (DCI)
Time frame: After onset, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor functional outcome measured by the Fugl-Meyer Assessment (FMA) (time frame: 3 to 6 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.