HeadacheHEALTHNCT07269561
Headache Registration and Followup Initiated by Tongji Hospital, HUST
An observational study of Headache and Comorbidities, run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Headache, Comorbidities
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Han Dr, MD PhD, +8618627023031 ext. +86-2783663337, 523852566@qq.com
Qu Professor, MD PhD, +8618971622660 ext. +86-2783663337, wsqu@tjh.tjmu.edu.cn
About this study
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.
Read the 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:
- 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.
- Conditions
- Headache, Comorbidities
- Keywords
- Headache, prediction models, database, cohort, Real world observation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wensheng Qu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269561
- Sponsor's protocol ID
- TJ-headache
- Other IDs
- 2022ACA005
- Acronym
- HEALTH
- Status last verified
- Jan 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Registration and Followup Initiated by Tongji Hospital, HUST
- ClinicalTrials.gov ID
- NCT07269561
- Acronym / sponsor ID
- HEALTH / TJ-headache
- Conditions
- Headache, Comorbidities
- Keywords
- Headache, prediction models, database, cohort, Real world observation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Brain network characterization and biomarker identification
Time frame: Baseline and annual follow-up for 5 years
Clinical efficacy of treatment approaches
Time frame: Baseline and annual follow-up for 5 years
Novel therapeutic target identification
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache and Comorbidities, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wensheng Qu Professor, DM PhD (+8618971622660, wsqu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of integrated precision diagnosis and treatment system for headache (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.