Headache Registration and Followup Initiated by Tongji Hospital, HUST

Overview

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:

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.

Primary outcome measures

• Development of integrated precision diagnosis and treatment system for headache [Time frame: 5 years]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07269561 · TJ-headache · 2022ACA005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗