Clinical trial NCT05334927: China HeadAche DIsorders RegiStry
Official title: China HeadAche DIsorders RegiStry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Headache Disorders, Primary
Migraine
New Daily Persistent Headache
Medication Overuse Headache
Tension-Type Headache
Trigeminal Autonomic Cephalalgia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary headache (migraine, tension headache and other types of primary headache) or primary headache complicated with MOH according to ICHD-3.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Headache Days
timeFrame: long term: 10 years
measure: MRI change
timeFrame: long term: 10 years
measure: Genetic analysis of familial headache
timeFrame: 1 year
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: long term: 10 years
measure: Mini-Mental State Exam (MMSE)
timeFrame: long term: 10 years
measure: Migraine Disability Assessment (MIDAS)
timeFrame: long term: 10 years
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: long term: 10 years
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: long term: 10 years
Secondary outcomes:
measure: Social and demographic data, medical history
timeFrame: long term: 10 years
measure: Use of Rescue Medication
timeFrame: long term: 10 years
measure: Moderate / Severe Headache Days
timeFrame: long term: 10 years
measure: Pain severity
timeFrame: long term: 10 years
measure: MEG
timeFrame: long term: 10 years
measure: PET
timeFrame: long term: 10 years
measure: EEG
timeFrame: long term: 10 years
measure: Proteomics
timeFrame: 1 year
measure: Microbiome
timeFrame: 1 year
measure: Headache Impact Test (HIT-6)
timeFrame: long term: 10 years
measure: European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
timeFrame: long term: 10 years
measure: Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)
timeFrame: long term: 10 years
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: long term: 10 years
measure: Columbia-Suicide Severity Rating Scale
timeFrame: long term: 10 years
Other outcomes:
Locations:
Study officials:
References: