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HealthyNCT06643858

Normal Chinese Lifespan Brain Charts Initiative (NCLBCI)

An observational study of Healthy and Multiple Sclerosis, run by Beijing Tiantan Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 6 to 90 yearsHealthy volunteers can take part
How many people
10,000 participants
Where
1 siteChina
Study dates
1 Dec 2023to 1 Dec 2026
Phase
Observational

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 6 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: Establishment of Chinese Brain Charts for Individualized Diagnosis of Major Brain Diseases

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.

Read the detailed description

In 2022, the World Health Organization (WHO) issued a policy document calling for attention to brain health and neurological diseases. In China's "14th Five-Year Plan," brain science research is designated as one of the key research areas, with the development goal of promoting the understanding of fundamental brain mechanisms and meeting the needs for improving brain health in the population. Understanding brain development and aging in healthy individuals is a prerequisite for comprehending neurological diseases. The function of the blood-brain barrier is crucial to maintaining brain health and plays a central role in the occurrence and development of major brain diseases. However, there is currently a lack of standardized reference values for brain structural imaging evaluation, and even less is known about the changes in blood-brain barrier function in healthy populations. This significantly hinders the understanding of brain health, the pathology of major brain diseases, and the ability to make early individualized diagnoses and treatments. Additionally, although functional Magnetic Resonance Imaging (fMRI) has become an essential research tool in neuroscience, its clinical application is still fraught with difficulties, primarily due to the lack of standardized quantitative evaluation methods. In 2022, international datasets covering the human lifespan were established, and the constructed percentile curves revealed population patterns of brain development and individualized differences, offering a promising standardized tool for evaluating brain health and diseases. Nevertheless, existing brain imaging characterizations still have some limitations: (1) the lack of normal reference values for brain imaging structures in the Chinese population; (2) the absence of brain function indicator charts, such as functional connectivity and cerebral blood flow perfusion, especially with regard to the critical role of blood-brain barrier changes in major brain disease transformation; (3) The application value of brain charts in the diagnosis and treatment of major brain diseases lacks systematic research. Therefore, constructing brain structure and function imaging charts (normal reference values) for the Chinese population is imperative and represents a pressing scientific and clinical issue that needs to be addressed.

Establishment of the Chinese Normal Population Neuroimaging Database: The investigators aim to establish the largest neuroimaging research cohort in China, consisting of 10,000 participants, with a wide age range (6-90 years), balanced gender distribution, and representation from more than 30 centers nationwide, ensuring a balanced distribution of scanning devices. Using federated machine learning methods, the study will address data privacy and security concerns. This project primarily includes: ① Retrospective collection of neuroimaging data from 5,000 participants nationwide, focusing mainly on 3DT1WI and 3DFLAIR imaging, and also collecting basic demographic information, health status, and neuropsychological assessments. ② A prospective neuroimaging cohort of 5,000 participants from the Chinese normal population, including multimodal imaging sequences (3DT1WI, 3DFLAIR, DKI, ASL, VEXI, MRA, and resting-state fMRI), along with detailed demographic information, neuropsychological assessments, standardized questionnaires, and basic physical examinations. Multimodal neuroimaging data and neuropsychological assessments will be collected at two follow-ups (1-year and 2-year intervals). Among the multimodal brain imaging collected, the method reflecting blood-brain barrier permeability is vascular water exchange MRI (VEXI), which uses water molecules as natural internal tracers to measure blood-brain barrier function.

Establishment of Brain Structure and Function Charts for the Chinese Normal Population: Based on retrospective and prospective neuroimaging data from the Chinese normal population, standardized modeling methods (including Generalized Additive Mixed Models [GAMLSS] and Gaussian Process Regression [GPR]) will be used to create structural brain charts. These charts will include: ① Whole brain volumes (Gray Matter Volume [GMV], White Matter Volume [WMV], Total Intracranial Volume [TIV], etc.), the volumes of 148 brain regions, and subcortical nuclei volumes. ② White matter fiber tracts (48 white matter fiber tracts and diffusion metrics, including Fractional Anisotropy [FA], Mean Kurtosis [MK], Mean Diffusivity [MD], etc.) and functional brain charts, which include: ① Blood-brain barrier permeability; ② Cerebral blood flow (CBF); ③ Local brain activity indicators (Regional Homogeneity [ReHo], Amplitude of Low-Frequency Fluctuations [ALFF], etc.); ④ Global functional connectivity; and ⑤ Brain network analysis (local and global efficiency), among others.

Being tested
No intervention
Keywords
Brain Charts, Individualized Diagnosis
Medical subject headings
Multiple Sclerosis, Neuromyelitis Optica, Neurodegenerative Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    This study does not involve any interventions.

Study groups in NCT06643858
Study groupRoleWhat they receive
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.
Receives: 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).
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: December 2023 - May 2025

  2. 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.

    Measured: December 2023 - November 2025

  3. 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.

    Measured: December 2024 - May 2026

  4. 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.

    Measured: June 2025 - May 2026

  5. 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.

    Measured: June 2026 - November 2026

Secondary outcomes (2)
  1. Number of Peer-Reviewed Papers Published and Patents Filed

    The outcome will be the total number of peer-reviewed scientific papers published (targeting 3-4) and the number of national invention patents filed (targeting 5-7). This includes metrics for the quality of journals (impact factors) and patent filing stages (application, approval).

    Measured: June 2024 - November 2026

  2. Number of Multicenter Sites Using Brain Charts for Clinical and Research Purposes

    The outcome will measure the number of additional multicenter sites that have adopted and integrated the brain charts into their clinical and research workflows. This will include the number of sites actively participating in ongoing validation and refinement of the brain charts, with metrics for data sharing, collaboration, and feedback implementation.

    Measured: December 2025 - November 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Other
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06643858
Sponsor's protocol ID
KY2024-221-02
Status last verified
Dec 2025
First submitted
24 Sep 2024
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Clinical and MR data can be shared.

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