No intervention: This study does not involve any interventions.
Study summary
Major brain diseases (including neuroimmune diseases, neurodegenerative diseases, and cerebrovascular diseases) are leading causes of death and disability in humans. This research will gather brain imaging data from more than 10,000 participants across multiple age groups from multiple centers nationwide. Using standardized modeling methods, the investigators aim to establish normal brain imaging reference values for the Chinese population. (1) The study will reveal population-level patterns of brain structure changes and determine normal reference values for brain structure at different ages. (2) Non-invasive imaging methods will be applied to evaluate blood-brain barrier changes without the need for invasive procedures, establishing age-related permeability patterns and normal values in healthy populations. Additionally, functional magnetic resonance imaging (fMRI) will be combined to provide brain function indicators at various scales, creating comprehensive multi-dimensional function charts. (3) These brain structure and function charts will be applied to the individualized diagnosis and treatment of major brain diseases, including neuroimmune diseases (Multiple Sclerosis \[MS\], Neuromyelitis Optica Spectrum Disorders \[NMOSD\]), neurodegenerative diseases (Alzheimer's disease \[AD\], Parkinson's disease \[PD\]), and cerebrovascular diseases (Cerebral Small Vessel Diseases \[cSVD\]). This approach will facilitate early disease diagnosis and provide precise, individualized assessments of treatment efficacy and prognosis prediction. The established brain structure and function charts will be accessible via interactive websites or software, enabling real-time online data updates and individualized percentile outputs for brain structure and function. By inputting the target data, users can obtain individualized evaluation metrics for brain structure and function. The project's implementation and application hold great potential for broad use, promotion, and high translational potential.
Eligibility
Sex
ALL
Min age
6 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Healthy individuals with normal physical function who can lie supine without medical issues (e.g., no difficulty breathing, physical pain, nausea, or dizziness);
2. No claustrophobia;
3. No metal implants in the body (e.g., metal teeth, intrauterine devices, pacemakers, etc.).
Exclusion Criteria:
1. Presence of metal implants in the body;
2. Individuals who have undergone aneurysm surgery or have aneurysm clips in the brain;
3. Contraindications to MRI examination;
4. Prospective cohort participants who are unable to meet follow-up requirements.
Primary outcome measure(s)
Number of Brain Imaging Scans Collected and Processed Across Multiple Centers — December 2023 - May 2025 The primary outcome will be the total number of brain imaging scans (including 3DT1WI, 3DFLAIR, DKI, ASL, VEXI, MRA, and resting-state fMRI) successfully collected and processed across multiple centers. These scans will be aggregated by type (e.g., 3DT1WI, 3DFLAIR) and by imaging modality. Standardized imaging processing methods will be applied to ensure consistency in data quality and preparation for constructing brain structure and function charts.
Accuracy and Reliability of Structural Brain Chart Models — December 2023 - November 2025 The primary outcome will be the accuracy and reliability of the structural brain chart models, assessed through metrics such as mean absolute error (MAE), R-squared (R²), and Z-scores across multiple centers. Model performance will be evaluated based on the deviation of predicted brain structure volumes (e.g., gray matter volume, white matter volume, total intracranial volume) from actual collected data. Validation will include testing the charts on retrospective and prospective datasets from the primary center and additional participating centers. The models will be optimized iteratively based on these evaluations.
Accuracy and Reliability of Functional Brain Chart Models — December 2024 - May 2026 The outcome will be the accuracy and reliability of the functional brain chart models, assessed using metrics such as correlation coefficients, Z-scores, and functional connectivity strength across multiple brain regions. The performance will be validated using longitudinal multimodal functional brain data (e.g., resting-state fMRI, cerebral blood flow, regional homogeneity). Model reliability will be evaluated by comparing predicted functional measures with observed data across longitudinal time points.
User Access and Interaction Metrics on Brain Chart Online Platform — June 2025 - May 2026 The outcome will measure the number of user interactions and successful use cases on the real-time interactive online platform. Key metrics will include the number of users, frequency of data input and retrieval, and the accuracy of the generated individualized brain structure and function parameters based on user-provided data. Platform reliability and performance will be validated through user feedback and system testing.
Number of Brain Chart Products Released and Marketed — June 2026 - November 2026 The outcome will measure the number of brain chart products that have been successfully productized and promoted for market application. This includes the completion of product development, official product launches, and market penetration metrics such as user adoption rates and commercial distribution.
Trial sites (1)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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