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.
Study Type
OBSERVATIONAL
Enrollment
10,000
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.
long-term follow-up
No collection Brain imaging、Cognitive function test、Biological sample
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 acute treatment) and longitudinal symptom measures at weeks 4, 8, and 12 (for those receiving preventive management).
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 approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).
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 approximately 4-week intervals during the 12-week observation window (and additional follow-up when available).
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chaoyang Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing People's Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
RECRUITINGThe First People's Hospital of Zunyi
Zunyi, Guizhou, China
RECRUITINGRuijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
Qionghai, Hainan, China
RECRUITINGZhangjiakou First Hospital
Zhangjiakou, Hebei, China
RECRUITINGLuohe Central Hospital
Luohe, Henan, China
RECRUITINGLuoyang Central Hospital
Luoyang, Henan, China
RECRUITING...and 10 more locations
Headache Days
The number of days of headache is the number of days in which headache occurs.
Time frame: long term: 10 years
MRI change
Patients will accept MRI scans will be done at baseline and once per year.
Time frame: long term: 10 years
Genetic analysis of familial headache
Blood samples will be collected from all participants who consent to participate in the study, for the purposes of genetic analysis of familial headache.
Time frame: 1 year
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess changes in cognitive functions.
Time frame: long term: 10 years
Mini-Mental State Exam (MMSE)
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used in clinical and research settings to assess cognitive function.
Time frame: long term: 10 years
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7-item questionnaire designed to quantify headache-related disability over a 3- month period. The MIDAS score is the sum of missed work or school days, days at work or school plus days of household work where productivity was reduced by half or more, missed household work days, and missed non-work activity days due to headaches in the last 3 months.
Time frame: long term: 10 years
Generalized Anxiety Disorder (GAD-7)
GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The GAD-7 scale score ranges from 0 to 21.
Time frame: long term: 10 years
Patient Health Questionnaire (PHQ)-9
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Time frame: long term: 10 years
Pain freedom at 2 hours
It refers to the complete resolution of headache symptoms within 2 hours after taking the investigational drug, without the use of any rescue medication, and without recurrence of headache during this period.
Time frame: 2 hours post-dose
Social and demographic data, medical history
Social and demographic data, medical and medication history will be collected at initial screening.
Time frame: long term: 10 years
Use of Rescue Medication
Frequency of Rescue medication will be collected by eDiary.
Time frame: long term: 10 years
Moderate / Severe Headache Days
Moderate / severe headache days are defined as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. These definitions allow the use of relatively simple headache diaries. Subjects were required to indicate whether headache was present (yes / no), peak (mild / moderate / severe) severity and duration (\< 4h or 4h), type of acute drug intake, and response to treatment should also be recorded.
Time frame: long term: 10 years
Pain severity
Pain severity were captured through Visual analogue scale (VAS) for pain, a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
Time frame: long term: 10 years
MEG
Patients will accept MEG.
Time frame: long term: 10 years
PET
Patients will accept PET scan.
Time frame: long term: 10 years
EEG
Patients will accept EEG scan.
Time frame: long term: 10 years
Proteomics
Blood, urine and Cerebrospinal fluid samples will be collected from all participants who consent to participate in the study, for the purposes of Proteomics at baseline and month 12.
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Time frame: 1 year
Microbiome
Saliva samples will be collected from all participants who consent to participate in the study, for the purposes of Microbiome at baseline and month 12.
Time frame: 1 year
Headache Impact Test (HIT-6)
The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function.
Time frame: long term: 10 years
European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
EQ-5D-3L is a generic instrument for use as a measure of health status. The EQ-5D-3L consists of 2 components-the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labelled "Best imaginable health state" and "Worst imaginable health state." The scoring range of the EQ VAS is from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: long term: 10 years
Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.
Time frame: long term: 10 years
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep.
Time frame: long term: 10 years
Columbia-Suicide Severity Rating Scale
C-SSRS will be administered to study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.
Time frame: long term: 10 years
Absence of the most bothersome symptom
It refers to the complete resolution of the patient's self-identified most bothersome migraine-associated symptom (including photophobia, phonophobia, nausea, etc.) within 2 hours after taking the study medication.
Time frame: 2 hours post-dose
Patient Global Impression of Change (PGIC) Scale
The Patient Global Impression of Change (PGIC) Scale is a single-item, patient-reported measure of overall change in symptoms, activity limitation, mood, and overall quality of life since starting treatment at this institution. Scores range from 1 to 7, where 1 = no improvement (or condition worsened) and 7 = very large improvement; higher scores indicate better improvement (better outcome).
Time frame: 10 years
Fatigue Impact Scale (FIS)
Fatigue Impact Scale (FIS) is a standardized questionnaire assessing the impact of fatigue on daily functioning (cognitive, physical, and psychosocial domains). Each item is scored 0-4; the total score ranges from 0 to 160 (sum of 40 items). Higher scores indicate greater fatigue impact (worse outcome).
Time frame: 10 years