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Establishment of Chinese Brain Charts for Individualized Diagnosis of Major Brain Diseases
Sponsor study identifier
observational
10,000
1 country
1
Study Start
December 1, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2023
Actual (reported)September 24, 2024
Actual (reported)October 16, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Brain Imaging Scans Collected and Processed Across Multiple Centers
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.
December 2023 - May 2025
Accuracy and Reliability of Structural Brain Chart Models
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.
The primary imaging modalities include 3D T1-weighted imaging (3D T1WI) and 3D fluid-attenuated inversion recovery (3D FLAIR), along with basic demographic information, health status, and neuropsychological assessments.
This cohort will include multimodal imaging sequences (3D T1-weighted imaging, 3D FLAIR, diffusion kurtosis imaging \[DKI\], arterial spin labeling \[ASL\], vascular water exchange imaging \[VEXI\], magnetic resonance angiography \[MRA\], and resting-state functional MRI \[rest-fMRI\]). Detailed demographic information, neuropsychological assessments, standardized questionnaires, and basic physical examinations will also be collected. Multimodal neuroimaging data and neuropsychological assessments will be followed up twice (at 1 year and 2 years).
This study does not involve any interventions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy individuals aged 6 to 90 years are eligible to participate in the study.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Yaou Liu, Doctor
Beijing Tiantan Hospital
First Submitted
September 24, 2024
First Posted
October 16, 2024
Study Start
December 1, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)December 2023 - November 2025
Accuracy and Reliability of Functional Brain Chart Models
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.
December 2024 - May 2026
User Access and Interaction Metrics on Brain Chart Online Platform
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.
June 2025 - May 2026
Number of Brain Chart Products Released and Marketed
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.
June 2026 - November 2026
Number of Peer-Reviewed Papers Published and Patents Filed
June 2024 - November 2026
Number of Multicenter Sites Using Brain Charts for Clinical and Research Purposes
December 2025 - November 2026
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 30, 2025
Record last verified: 2025-12
Clinical and MR data can be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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