Clinical Features and Current Treatment of Primary Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disease education, pharmacological treatment, Non-pharmacological treatment.
- Who it may be relevant to
- Registry conditions: Primary Headache. Basic parameters: up to 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of the Clinical Features and Current Treatment of Primary Headache
Overview
This study is a prospective, observational cohort study. The plan of this study is to consecutively enroll 2,000 primary headache patients who meet the inclusion criteria from the neurology outpatient department and inpatient department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Basic clinical data registration, various scale evaluations, cranial imaging examinations, and collection of blood and fecal biological samples will be completed. During the 10-year follow-up plan, systematic clinical evaluations of the disease severity, diagnosis and treatment, living ability and health status of patients will be carried out regularly every 6 - 12 months. Imaging and other functional evaluations will be conducted when necessary. Data collection includes: Demographic data (including age, gender, education, ethnicity, marital status, occupation, etc.); General clinical data (past medical history, medication history, personal history, menstrual and childbearing history, family history, etc.); Clinical data of primary headache: headache frequency, duration, severity (Numeric Rating Scale for pain, NRS), headache-related medication use, drug efficacy and side effects; Scale evaluations: MIDAS, HIT-6, BPI, MSQ, ADL, CDR, PGIC, CGIC, PHQ-4, mTOQ-4, ASC-12, MIBS-4, HARDSHIP, WHO-QOL BREF, HAMD, HAMA, TNQ; Records of neurological imaging examinations, blood sample and fecal sample collection.
Detailed description
Background Headache is one of the most common diseases in the nervous system. Approximately 52% of adults worldwide suffer from primary headache. The third edition of the International Classification of Headache Disorders in 2018 classified primary headache into migraine, tension-type headache, trigeminal autonomic cephalalgia, and other primary headaches. Although primary headache has no obvious organic lesions, it can lead to transient or permanent central nervous system dysfunction, affecting people's daily life and work, and imposing a huge economic burden on society. This study intends to establish a prospective cohort of patients with primary headache, observe the relevant risk factors, clinical treatment efficacy, and prognosis of patients with primary headache, and explore the relevant clinical factors and biomarkers for a favorable prognosis. During the 10-year follow-up plan, systematic clinical evaluations will be regularly carried out on the disease severity, diagnosis and treatment status, living ability, and health status of patients. When necessary, blood and fecal samples will be collected and imaging evaluations will be conducted to complete the construction of a clinical diagnosis and treatment information database for patients with primary headache, and analyze the clinical factors related to the prognosis.
Research Objectives To observe the risk factors, clinical characteristics, treatment regimens and their efficacy, and prognosis of patients with primary headache, and to explore the relevant clinical factors and biomarkers for a favorable prognosis.
Research Design This study adopts a single-center, prospective cohort design.
Baseline Assessment Demographic data (including: age, gender, education level, ethnicity, marital status, occupation, etc.); General clinical data (past medical history, medication history, personal history, menstrual, marital and childbearing history, and family history, etc.); Clinical data of primary headache: headache frequency, duration, severity (Numerical Rating Scale for Pain, NRS), past headache-related medication use, medication efficacy and side effects; Scale Evaluation: MIDAS, HIT-6, BPI, MSQ, ADL, CDR, PGIC, CGIC, PHQ-4, mTOQ-4, ASC-12, MIBS-4, HARDSHIP, WHO-QOL BREF, HAMD, HAMA, TNQ; Biochemical Indicators: White blood cell count and classification, inflammatory indicators in the blood; fecal bacteriological examination; Changes in Imaging Biomarkers: Changes in brain structure, brain function, and metabolism.
Follow-up Study
Within 6 months after enrollment, follow-up assessments will be conducted every 1-3 months; from half a year to 10 years after enrollment, follow-up assessments will be conducted every 6-12 months (the assessment methods include in-person interviews, telephone follow-ups, and online follow-ups). The following data will be collected:
Clinical data of primary headache: headache frequency, duration, severity (Numerical Rating Scale for Pain, NRS), the use of headache-related medications (types, dosages, efficacy, and side effects); Scale Evaluation: MIDAS, HIT-6, BPI, MSQ, ADL, CDR, PGIC, CGIC, PHQ-4, mTOQ-4, ASC-12, MIBS-4, HARDSHIP, WHO-QOL BREF, HAMD, HAMA, TNQ; Blood and fecal tests and cranial imaging examinations (when clinically necessary and with the patient's/family member's consent and cooperation).
Interventions
- Combination product Disease education, pharmacological treatment, Non-pharmacological treatment
Disease education: Provide patients with education on knowledge related to primary headache, including the causes, pathogenesis, symptoms, treatment methods, and preventive measures of headache, etc., to help patients better understand their own diseases and improve their self-management ability. Non-pharmacological treatment: Although specific non-pharmacological treatment methods are not elaborated in detail in the research protocol, they may include psychotherapy, physical therapy, etc. For
Primary outcome measures
- The number of headache days per month. [Time frame: 10 years]
- Changes in scores of headache assessment scales: NRS. [Time frame: 10 years]
- Changes in scores of headache assessment scales: HIT-6. [Time frame: 10 years]
Secondary outcome measures (12)
- The number of days of emergency medication use per month. [Time frame: 10 years]
- The types of preventive medications and the number of days of use per month. [Time frame: 10 years]
- Changes in scale scores at MIDAS. [Time frame: 10 years]
- Changes in scale scores at BPI. [Time frame: 10 years]
- Changes in scale scores at MSQ. [Time frame: 10 years]
- Changes in scale scores at PGIC and CGIC. [Time frame: 10 years]
- Changes in scale scores at HAMD and HAMA. [Time frame: 10 years]
- Changes in scale scores at WHO - QOLBREF. [Time frame: 10 years]
- Changes in scale scores at HARDSHIP. [Time frame: 10 years]
- Concentration of White Blood Cell Count and Subtypes in Peripheral Blood. [Time frame: 10 years]
- Change in serum inflammatory cytokine levels. [Time frame: 10 years]
- Diversity and Abundance of Fecal Microbiota. [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Age is less than 65 years old.
- Meets the diagnostic criteria for relevant primary headaches (such as tension-type headache, migraine, cluster headache, trigeminal autonomic cephalalgia, etc.) in the third edition of the International Classification of Headache Disorders (ICHD - 3).
- Is willing and able to participate throughout the entire study period and sign the informed consent form.
- Has the ability to complete the "Headache Diary" independently or with the help of a guardian.
Exclusion criteria
- Secondary headache
- High - risk populations, such as those with severe heart disease, impaired liver and kidney function, malignant tumors, etc.
- Patients with mental illness, cognitive impairment, or those who are unable to cooperate with the research requirements
- History of intracranial lesions or other nervous system diseases (including stroke, epilepsy, etc.)
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
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou
Publications
- Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2. PMID 35410119
- Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137. doi: 10.1186/s10194-020-01208-0. No abstract available. PMID 33267788
Identifiers
NCT: NCT06883955 · SYSKY-2025-081-01