China HeadAche DIsorders RegiStry

Обзор

It is planned to include 10000 patients. In the China HeadAche DIsorders RegiStry CHAIRS）, patients aged over 12 years with primary headache and medication-overuse headache(MOH) were collected. The biomarkers, imaging features, cognition, genetic characteristics, ocial and demographic data, medical data, therapeutics used, and outcome of headache-related diseases were studied, and long-term follow-up was planned.

Вмешательства

• Поведенческое Medicine Overuse Headache/New Daily Persistent Headache
  At the end of the 24th month visit, the patient is free to choose whether to conduct a face-to-face visit once a year until death.
• Поведенческое Episodic Migraine and Chronic Migraine
  long-term follow-up
• Поведенческое Patients with other types of primary headache
  No collection Brain imaging、Cognitive function test、Biological sample
• Препарат Yangxue Qingnao Granules (Pills)
  Participants who, in routine clinical practice, were prescribed Yangxue Qingnao Granules/Pills for acute headache relief and/or preventive management were enrolled. Treatment initiation, dosing, frequency, and duration were determined by the treating physician and the patient and were not assigned by the study protocol. During the 12-week observation period, participants were followed and outcomes were recorded, including relief of up to four headache episodes (for those using the medication for
• Биопрепарат Erenumab
  Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approxima
• Биопрепарат Eptinezumab
  Participants who received eptinezumab for migraine prophylaxis in routine clinical practice were included. Treatment decisions (including whether to initiate eptinezumab, the selected dose \[e.g., 100 mg or 300 mg\], infusion interval, and duration) were made by the treating physician in consultation with the patient, and were not assigned by the study protocol. Patients were followed prospectively/retrospectively according to routine clinic visits, with outcome assessments captured at approxima

Первичные конечные точки

• Headache Days [Срок оценки: long term: 10 years]
• MRI change [Срок оценки: long term: 10 years]
• Genetic analysis of familial headache [Срок оценки: 1 year]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: long term: 10 years]
• Mini-Mental State Exam (MMSE) [Срок оценки: long term: 10 years]
• Migraine Disability Assessment (MIDAS) [Срок оценки: long term: 10 years]
• Generalized Anxiety Disorder (GAD-7) [Срок оценки: long term: 10 years]
• Patient Health Questionnaire (PHQ)-9 [Срок оценки: long term: 10 years]
• Pain freedom at 2 hours [Срок оценки: 2 hours post-dose]

Вторичные конечные точки (12)

• Social and demographic data, medical history [Срок оценки: long term: 10 years]
• Use of Rescue Medication [Срок оценки: long term: 10 years]
• Moderate / Severe Headache Days [Срок оценки: long term: 10 years]
• Pain severity [Срок оценки: long term: 10 years]
• MEG [Срок оценки: long term: 10 years]
• PET [Срок оценки: long term: 10 years]
• EEG [Срок оценки: long term: 10 years]
• Proteomics [Срок оценки: 1 year]
• Microbiome [Срок оценки: 1 year]
• Headache Impact Test (HIT-6) [Срок оценки: long term: 10 years]
• European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) [Срок оценки: long term: 10 years]
• Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) [Срок оценки: long term: 10 years]

Критерии участия

Критерии включения

• Age ≥ 12 years old,Any gender;
• The first onset age of primary headache was less than 50 years old(Age <65 years at first diagnosis of chronic migraine);
• patients with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3;
• Sign the informed consent form.

Критерии исключения

• According to the ICHD-3 diagnostic criteria, there are still headaches directly related to secondary factors (except drug overuse) at the time of enrollment;
• Those who cannot be diagnosed as primary headache or primary headache combined with medication overuse headache according to ICHD-3;
• According to DSM-V diagnostic criteria, patients with severe mental diseases (such as schizophrenia, mental disorders associated with mental retardation, etc.);
• Patients with severe organic diseases, such as malignant tumors, and the expected survival time is less than 1 year;
• Pregnant,planning pregnancy or Lactating women;
• Subjects participating in other clinical trials;
• Unable to cooperate to complete the follow-up due to geographical or other reasons

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 61 центр

• Anqing Municipal Hospital — Anqing
• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital) — Wuhu
• Beijing Tiantan Hospital, Capital Medical University — Пекин
• Beijing Chaoyang Hospital — Пекин
• Peking University Third Hospital — Пекин
• The First Hospital of Fangshan District, Beijing — Пекин
• Chongqing People's Hospital — Чунцин
• The Third Affiliated Hospital of Chongqing Medical University — Чунцин
• … и ещё 53 центра

Публикации

• Li X, Li R, Liu G, Qiu D, Mei Y, Xiong Z, Yuan Z, Zhang P, Zhang M, Liu X, Tang H, Zhang Y, Yu X, Liu Y, Sui B, Wang Y. Iron deposition network mapping of disease occurrence and clinical manifestations in migraine: A prospective study. Cephalalgia. 2026 Jan;46(1):3331024261416488. doi: 10.1177/03331024261416488. Epub 2026 Jan 28. PMID 41603449
• Lin C, Li Y, Wang Z, Duan C, Liu G, Guo Z, Li X, Xiong Z, Chen T, Zhang M, Gao T, Sui B, Wang Y. Abnormal neurovascular coupling in the precuneus associated with migraine chronification: A multimodal magnetic resonance imaging study. Cephalalgia. 2025 Nov;45(11):3331024251396031. doi: 10.1177/03331024251396031. Epub 2025 Nov 12. PMID 41223010
• Xiong Z, Qiu D, Liang J, Li X, Guo Z, Zhang M, Liu G, Gao T, Wang Y. Disrupted functional network topology in tension-type headache: A cross-sectional magnetoencephalography study. Cephalalgia. 2025 Oct;45(10):3331024251386425. doi: 10.1177/03331024251386425. Epub 2025 Oct 15. PMID 41091912
• Wang W, Qiu D, Mei Y, Bai X, Yuan Z, Zhang X, Xiong Z, Tang H, Zhang P, Zhang Y, Yu X, Wang Z, Ge Z, Sui B, Wang Y. Altered functional connectivity of brainstem nuclei in new daily persistent headache: Evidence from resting-state functional magnetic resonance imaging. CNS Neurosci Ther. 2024 Mar;30(3):e14686. doi: 10.1111/cns.14686. PMID 38516817
• Wang W, Yuan Z, Zhang X, Bai X, Tang H, Mei Y, Qiu D, Zhang Y, Zhang P, Zhang X, Zhang Y, Yu X, Sui B, Wang Y. Mapping the aberrant brain functional connectivity in new daily persistent headache: a resting-state functional magnetic resonance imaging study. J Headache Pain. 2023 Apr 26;24(1):46. doi: 10.1186/s10194-023-01577-2. PMID 37098469

Идентификаторы

NCT: NCT05334927 · KY2022-tt02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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