International Headache Registry Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Headache Disorders, Primary, Headache Disorders, Secondary, Migraine, Tension-Type Headache. Basic parameters: 4 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
International Headache and Vertigo Registration Study
Overview
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.
Detailed description
1. Research contents:
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned. 2. Research target:
We study biomarkers, imaging features, right-to-left shunt of heart (lung), genetic features, real-world treatment studies, and outcomes (in relation to other diseases) for headache and vertigo related diseases.
Primary outcome measures
- Days of Migraine [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Moderate / Severe Headache Days [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Attack [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
Secondary outcome measures (12)
- The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Headache Intensity [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Cumulative Hours of Moderate / Severe Pain at 28 Days [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Days Without Symptoms [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Days Without Headache [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Peak Headache Pain Intensity [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Disability Assessment (MIDAS) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Headache Impact Scale (HIT-6) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Migraine Specific Quality of Life Questionnaire (MSQV2.1) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Patient Health Questionnaire (PHQ-9) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Generalized Anxiety Disorder (GAD-7) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
- Functional Impairment Scale (FIS) [Time frame: Medium term: within 6 months after initial diagnosis; long term: 60 years]
Eligibility criteria
Inclusion criteria
The following are requirements for entry into the study:
- Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study-specific procedures.
- Male or female participants ages 4 to 99 years, inclusive, at Visit 1.
- Headache patients meeting the diagnostic criteria for ICHD-3, including primary headaches such as migraine and tension tension-type headaches, secondary headaches, and patients who meet the headache diagnosis in the ICHD-3 appendix (including vestibular migraine).
Exclusion criteria
- Patients who were unable to complete scales such as headache diary.
- Patients denied or unable to be admitted for long-term follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Kaiming Liu — Hangzhou
Identifiers
NCT: NCT05418218 · 20220430