Normal Chinese Lifespan Brain Charts Initiative (NCLBCI)

NCT06643858 | Enrolling By Invitation DMC

• 1 other identifier: KY2024-221-02
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebrovascular Diseases; Healthy; Neuromyelitis Optica Spectrum Disorders; Neurodegenerative Diseases; Multiple Sclerosis

Keywords

Brain Charts; Individualized Diagnosis

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (2)

• 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

Study Arms (2)

Nationwide retrospective neuroimaging data collection (5,000 participants)

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.

Other: No intervention

Nationwide prospective neuroimaging cohort of the Chinese normal population (5,000 participants).

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).

Other: No intervention

Interventions

No intervention OTHER

This study does not involve any interventions.

Nationwide prospective neuroimaging cohort of the Chinese normal population (5,000 participants).; Nationwide retrospective neuroimaging data collection (5,000 participants)

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals aged 6 to 90 years are eligible to participate in the study.

You may qualify if:

• Healthy individuals with normal physical function who can lie supine without medical issues (e.g., no difficulty breathing, physical pain, nausea, or dizziness);
• No claustrophobia;
• No metal implants in the body (e.g., metal teeth, intrauterine devices, pacemakers, etc.).

You may not qualify if:

• Presence of metal implants in the body;
• Individuals who have undergone aneurysm surgery or have aneurysm clips in the brain;
• Contraindications to MRI examination;
• Prospective cohort participants who are unable to meet follow-up requirements.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica; Neurodegenerative Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yaou Liu, Doctor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 16, 2024
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 3 years after the end of the trial.
• Access Criteria: The neurosurgeon and radiologist submitting the application to Professor Liu.

Locations

CN (1)