Clinical Features and Current Treatment of Primary Headache

NCT06883955 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2025-081-01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Headache

Keywords

primary headache; prospective cohort study; clinical features; current treatment

Outcome Measures

Primary Outcomes (3)

• The number of headache days per month.

  The number of headache days per month: This indicator is used to count the actual number of days each research subject experiences headache symptoms within each month. Through the recording and analysis of the number of headache days per month, it can directly reflect the frequency of headache attacks, helping researchers understand the duration of the interference of primary headache with the daily life of patients, and further evaluate the severity and development trend of the disease.

  10 years

• Changes in scores of headache assessment scales: NRS.

  NRS (The Numerical Rating Scale for Pain) is a commonly used simple pain measurement tool. Patients select a value within the numerical range from 0 (representing no pain) to 10 (representing the most severe pain) according to the degree of pain they feel, to quantify the intensity of pain.

  10 years

• Changes in scores of headache assessment scales: HIT-6.

  The HIT - 6 scale (the Headache Impact Test - 6) is mainly used to evaluate the impact of headache on various aspects of patients' lives, such as daily activities, social interaction, work, etc.

  10 years

Secondary Outcomes (15)

• The number of days of emergency medication use per month.

  10 years

• The types of preventive medications and the number of days of use per month.

  10 years

• Changes in scale scores at MIDAS.

  10 years

• Changes in scale scores at BPI.

  10 years

• Changes in scale scores at MSQ.

  10 years

Study Arms (1)

primary headache

Subjects who are younger than 65 years old and meet 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).

Combination Product: Disease education, pharmacological treatment, Non-pharmacological treatment

Interventions

Disease education, pharmacological treatment, Non-pharmacological treatment COMBINATION_PRODUCT

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 example, biofeedback therapy, relaxation training, transcranial magnetic stimulation, etc. These can all be recorded as possible intervention measures. Pharmacological treatment: Record the medications used for the treatment of acute episodes and preventive treatment by patients during the research process, including the types of medications, dosages, frequency of use, etc. For instance, non-steroidal anti-inflammatory drugs and triptan drugs used during acute episodes, and β-blockers.

primary headache

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary headache is a common neurological disease worldwide, with a prevalence rate of approximately 10% - 20%. Its occurrence is not related to brain structural damage, infection, metabolic abnormalities, or other diseases, but is directly caused by the abnormal function of the central or peripheral nervous system. According to the ICHD-3, primary headache mainly includes migraine, tension - type headache, and cluster headache etc. The attack frequency, duration, and severity of primary headache show a high degree of heterogeneity. Primary headache is highly comorbid with anxiety, depression, and sleep disorders. The quality of life of patients with chronic primary headache significantly declines, and the work absenteeism rate and economic burden increase. Analgesic drugs are mainly used in the acute phase. Preventive treatment is applicable to patients with frequent or chronic attacks, and non-pharmacological interventions are also effective strategies.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Freshly collect the blood and feces of patients with primary headache to detect biomarker changes, including white blood cell quantification and classification, inflammatory indicators, and fecal bacteriological examination. For imaging biomarker changes: Observe changes in brain structure, brain function, and metabolism.

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yamei Tang, MD, PhD

CONTACT

86-13556001992; tangym@mail.sysu.edu.cn

Yi Li, MD, PhD

CONTACT

86-15018761512; eleam2002@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 19, 2025
• Study Start: March 8, 2025
• Primary Completion (Estimated): December 31, 2037
• Study Completion (Estimated): December 31, 2037
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CN (1)