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Clinical Features and Current Treatment of Primary Headache

NCT06883955 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-03-19

No results posted yet for this study

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

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 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.

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-08
Primary Completion
2037-12-31
Completion
2037-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883955 on ClinicalTrials.gov