Headache Registration and Followup Initiated by Tongji Hospital, HUST (HEALTH)

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Comorbidities

Detailed Description

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:

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

Initial data collection includes:

1. Epidemiological information
2. Clinical data
3. Imaging data
4. Questionnaire responses
5. 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:

1. Medication, clinical efficacy
2. Headache-related history records
3. Adverse reactions

Technical Framework:

1. Database Development:

   Establishment of several integrated databases:

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

2. Advanced Technical Applications:

   Implementation of cutting-edge biotechnologies:

   Immunotherapy approaches Multi-omics detection technologies Big data bioinformatics analysis

3. 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.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Wensheng Qu Professor, DM PhD; Phone Number: +8618971622660; Email: wsqu@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Han Zhang Dr, MD PhD; Phone Number: +8618627023031; Email: 523852566@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Han Dr, MD PhD; Phone Number: +86-2783663337 +8618627023031; Email: 523852566@qq.com
      • Contact: Qu Professor, MD PhD; Phone Number: +86-2783663337 +8618971622660; Email: wsqu@tjh.tjmu.edu.cn
      • Principal Investigator: Qu Professor, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Headache patients undergoing routine treatment; Fifty thousand headache patients from several headache centers in China will be recorded to establish a headache database. Data collection includes epidemiological information, clinical data, neuroimaging, questionnaires, and real-world treatments. A cohort of 1,500 headache patients at Tongji Hospital's Neurology Department will receive blood and multi-model imaging collections. The patients will receive monthly interviews and undergo annual telephone follow-ups for 10 years. This cohort will contribute to establishing an integrated database system combining clinical, biological, and multi-omics data for precision medicine development in headache treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and annual follow-up for 5 years
Clinical efficacy of treatment approaches	Treatment effectiveness assessment through standardized outcomes Correlation between imaging biomarkers and clinical improvement Predictive models for treatment response	Baseline and annual follow-up for 5 years
Novel therapeutic target identification	Discovery and validation of potential drug targets through: Multi-omics analysis Neuroimaging biomarkers Machine learning approaches	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal changes in brain structure and function	Tracking neuroimaging biomarkers and their relationship to clinical outcomes.	Annual assessment for 5 years
Database quality and integration	Evaluation of data completeness and successful integration of clinical, imaging, and molecular data.	Annual assessment for 5 years
Adverse events and follow-up compliance	Monitoring of treatment-related adverse events and follow-up completion rates.	Throughout study period, up to 5 years

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Headache; cohort; database; prediction models; Real world observation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache
• Other Study ID Numbers: TJ-headache; 2022ACA005 (Other Grant/Funding Number: Major science and technology project of Hubei Province, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this study, after de-identification (text, tables, figures, and appendices), will be available for academic purposes. The study protocol and statistical analysis plan will also be available.
• IPD Sharing Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No