Headache Registration and Followup Initiated by Tongji Hospital, HUST

NCT07269561 | Recruiting DMC

• 2 other identifiers: TJ-headache2022ACA005
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache; Comorbidities

Keywords

Headache; prediction models; database; cohort; Real world observation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Brain network characterization and biomarker identification

  Baseline and annual follow-up for 5 years

• Clinical efficacy of treatment approaches

  Baseline and annual follow-up for 5 years

• Novel therapeutic target identification

  5 years

Other Outcomes (3)

• Longitudinal changes in brain structure and function

  Annual assessment for 5 years

• Database quality and integration

  Annual assessment for 5 years

• Adverse events and follow-up compliance

  Throughout study period, up to 5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wensheng Qu Professor, DM PhD

CONTACT

+8618971622660; wsqu@tjh.tjmu.edu.cn

Han Zhang Dr, MD PhD

CONTACT

+8618627023031; 523852566@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and sign a data access agreement.

Locations

CN (1)