About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants will be recruited from several headache centers around China including Tongji Hospital. The study population includes patients aged 6-70 years diagnosed with headache according to ICHD-3 (2018) criteria. Eligible participants must be mentally competent to provide detailed headache history and demonstrate willingness to comply with follow-up assessments. Patients with complex headache etiology (≥3 distinct causal factors), severe systemic diseases, limited life expectancy (\<10 years), or significant cognitive/psychiatric impairments affecting study participation will be excluded. A total of 1,500 participants meeting these criteria will be enrolled and followed for 5 years.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Development of integrated precision diagnosis and treatment system for headache
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
Brain network characterization and biomarker identification
Structural and functional connectivity patterns from multimodal MRI HD-EEG spectral power and connectivity measures Integration with clinical and molecular data
Clinical efficacy of treatment approaches
Treatment effectiveness assessment through standardized outcomes Correlation between imaging biomarkers and clinical improvement Predictive models for treatment response
Novel therapeutic target identification
Discovery and validation of potential drug targets through: Multi-omics analysis Neuroimaging biomarkers Machine learning approaches
Other outcomes
Longitudinal changes in brain structure and function
Tracking neuroimaging biomarkers and their relationship to clinical outcomes.
Database quality and integration
Evaluation of data completeness and successful integration of clinical, imaging, and molecular data.
Adverse events and follow-up compliance
Monitoring of treatment-related adverse events and follow-up completion rates.
Sponsors and contacts
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