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NCT Number: NCT07269561

Headache Registration and Followup Initiated by Tongji Hospital, HUST

Headache is one of the most common chief complaints in clinical practice, with a high global prevalence rate. It may originate from a primary headache disorder or manifest as a clinical symptom of various diseases due to the complexity of its triggers, specific types, diagnosis, and treatment which present significant challenges. As people's life pace continues to accelerate and psychological and physiological pressures increase, many patients experience headache symptoms, leading to a growing number of patients seeking treatment in neurology departments. The increasing incidence of headache conditions has resulted in a decline in patients' quality of life.

Therefore, this research is part of Hubei Province's major project "Discovery and Functional Research of Major Disease Targets Based on Genetic Big Data." The study aims to establish a clinical cohort and develop a precise diagnosis and treatment system for headaches. This system will collect the history of headache sufferers, record the real-world treatment data, and incorporate sample banks, multi-dimensional databases, pre-clinical drug evaluation platforms, and clinical efficacy precise dynamic monitoring models through immunotherapy and other cutting-edge biotechnologies, multi-omics detection technologies, and big data bioinformatics analysis technologies.

The system will provide scientists and clinicians with auxiliary diagnostic and treatment decision support, offer reliable screening targets for early headache diagnosis and drug development companies, accelerate the latest headache diagnosis and targeted treatment, and achieve breakthrough advances in headache prevention and cure.

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Key information

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Han Dr, MD PhD

CONTACT

[email protected]

+8618627023031 ext. +86-2783663337

Qu Professor, MD PhD

CONTACT

[email protected]

+8618971622660 ext. +86-2783663337

Qu Professor, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

This research is a multi-center, prospective observational study focusing on headache patients, initiated by Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology (HUST). The study encompasses several key components:

  • Study Population and Data Collection:
  • Target enrollment: 50,000 with clinical data, and 1,500 headache patients with biological specimen collection
  • Recruitment site: Department of Neurology, Tongji Hospital; cooperate headache centers around China

Initial data collection includes:

  • Epidemiological information
  • Clinical data
  • Imaging data
  • Questionnaire responses
  • 5ml venous blood samples

Follow-up Protocol:

Duration: 10 years Follow-up intervals: face-to-face interviews during the first three months and telephone follow-ups by years

Monitoring parameters:

  • Medication, clinical efficacy
  • Headache-related history records
  • Adverse reactions

Technical Framework:

  • Database Development:

Establishment of several integrated databases:

Clinical database (epidemiological data, imaging, and EEG assessments) Biological sample repository Multi-omics bioinformatics database

  • Advanced Technical Applications:

Implementation of cutting-edge biotechnologies:

Immunotherapy approaches Multi-omics detection technologies Big data bioinformatics analysis

  • Analytical Components:

Development of machine learning algorithms Drug target evaluation systems Clinical efficacy monitoring models Outcome prediction models

Research Objectives Implementation:

Construction of molecular interaction networks related to headache Development of AI-based drug target assessment tools Establishment of standardized follow-up evaluation systems Validation of potential drug targets Creation of a comprehensive data-sharing platform

Expected Outcomes:

Enhanced understanding of headache pathogenesis Improved diagnostic capabilities Identification of novel therapeutic targets Development of personalized treatment approaches Establishment of a standardized evaluation system for clinical outcomes This detailed research framework aims to create a comprehensive precision medicine system for headache diagnosis and treatment, ultimately contributing to breakthrough advances in headache prevention and treatment strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meeting the diagnostic criteria for headache classification according to the International Classification of Headache Disorders 3rd edition (ICHD-3, 2018) Age between 6-70 years Voluntary participation with consent Good compliance with follow-up and questionnaire surveys

Exclusion criteria

  • Complex headache etiology, e.g., presence of ≥3 distinct factors causing headache Presence of severe systemic diseases or life expectancy less than 10 years Significant cognitive or psychiatric issues that prevent completion of questionnaire follow-ups and clinical assessments

Treatment and study plan

Primary outcomes

  1. Development of integrated precision diagnosis and treatment system for headache

    Time frame: 5 years

    Establishment and validation of a comprehensive system combining:

    Clinical database and biological repository real-world treatment and efficiency Multimodal neuroimaging biomarkers (MRI, EEG) Multi-omics data analysis to guide precise diagnosis and personalized treatment decisions.

Secondary outcomes

  1. Brain network characterization and biomarker identification

    Time frame: Baseline and annual follow-up for 5 years

    Structural and functional connectivity patterns from multimodal MRI HD-EEG spectral power and connectivity measures Integration with clinical and molecular data

  2. Clinical efficacy of treatment approaches

    Time frame: Baseline and annual follow-up for 5 years

    Treatment effectiveness assessment through standardized outcomes Correlation between imaging biomarkers and clinical improvement Predictive models for treatment response

  3. Novel therapeutic target identification

    Time frame: 5 years

    Discovery and validation of potential drug targets through:

    Multi-omics analysis Neuroimaging biomarkers Machine learning approaches

Other outcomes

  1. Longitudinal changes in brain structure and function

    Time frame: Annual assessment for 5 years

    Tracking neuroimaging biomarkers and their relationship to clinical outcomes.

  2. Database quality and integration

    Time frame: Annual assessment for 5 years

    Evaluation of data completeness and successful integration of clinical, imaging, and molecular data.

  3. Adverse events and follow-up compliance

    Time frame: Throughout study period, up to 5 years

    Monitoring of treatment-related adverse events and follow-up completion rates.

Study contacts

Contact information is provided by the study sponsor or research team.

Han Zhang Dr, MD PhD

CONTACT

[email protected]

+8618627023031

Wensheng Qu Professor, DM PhD

CONTACT

[email protected]

+8618971622660

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Acronym: HEALTH

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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