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.
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).
Patients who were unable to complete scales such as headache diary.
Patients denied or unable to be admitted for long-term follow-up.
Male or female participants ages 4 to 99 years
Cohort
Prospective
Not listed
Days of Migraine
The number of days of migraine is the number of days in which migraine occurs or is likely to be migraine (according to IHS ICHD-3 diagnostic criteria). A migraine day is a day when a headache lasts for more than 30 minutes, does not take painkillers, and meets the ICHD-3 migraine or most likely migraine criteria. Migraine day can also be defined as a headache day that is effective for the acute treatment of specific migraine drugs (triptan, ditan, gepant, ergotamine, etc.).
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 (triptan ergot / other), and response to treatment should also be recorded.
Migraine Attack
Migraine attack is defined as any consistent migraine attacks or the use of specific migraine drugs. If a migraine attack is interrupted by sleep, or temporarily relieved, and then relapses within 48 hours, it is considered an attack. In addition, migraine attacks that were successfully treated with drugs but relapsed within 48 hours and lasted for more than 48 hours were counted as one attack.
The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks
The response rate is calculated as the percentage reduction in the frequency of migraine attacks (or days of migraine, or days of moderate or severe headache) compared with the baseline during each treatment period. The response rate is traditionally defined as a reduction of at least 50% from the baseline, but other percentage reductions (for example: 30%, 75%, 100%) may be used.
Headache Intensity
Four-point rating scale was used to evaluate the headache intensity of each migraine day--painless, mild, moderate, or severe. Migraine intensity is not recommended as the main outcome measure alone, but it is important to record the decrease in migraine intensity as an indicator of disability reduction. Depending on the design of the trial, subjects should be asked to record the intensity of each migraine. In addition, the 11 point visual rating scale (VAS) can be used instead or in combination with the 4-level classification rating scale. The use of VAS in clinical trials may increase the likelihood of showing differences in severity.
Cumulative Hours of Moderate / Severe Pain at 28 Days
The cumulative number of hours of moderate / severe pain calculated by electronic headache diaries. If an attack occurs before going to bed and when you wake up, the amount of sleep also counts as the number of headache hours.
Days Without Symptoms
Defined as the number of days without aura, prodromal symptoms, headaches and subsequent symptoms. It needs to be determined by headache diary.
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Zhejiang University
Collaborator
First People's Hospital of Hangzhou
Collaborator
Affiliated Hospital of Shaoxing Wenli University
Collaborator
Tiantai County People's Hospital
Collaborator
People's Hospital of Lin 'an City
Collaborator
Deqing County People's Hospital
Collaborator
Jiaxing No.1 Hospital
Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborator
Shaoxing People's Hospital
Collaborator
Huzhou Central Hospital
Collaborator
The Affiliated Hospital of Hangzhou Normal University
Collaborator
Quzhou City People's Hospital
Collaborator
Xin Hua Hospital of Zhejiang Province
Collaborator
The First People's Hospital of Huzhou
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
Jiaxing Hospital of Traditional Chinese Medicine
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Affiliated Wenling Hospital of Wenzhou Medical University
Collaborator
Hangzhou Hospital of Traditional Chinese Medicine
Collaborator
Linhai First People's Hospital
Collaborator
Pain Management Center, Stanford University, USA
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
The Fourth Affiliated Hospital of Medical College of Zhejiang University
Collaborator
Chongqing Xinqiao Hospital
Collaborator
