China Headache and Vertigo Registry Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-99
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

In the Chinese 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Headache patients meeting the diagnostic criteria for ICHD-3, including primary headaches such as migraine and tension tension-type headaches, secondary headaches.

Patients who meet the headache diagnosis in the ICHD-3 appendix (including vestibular migraine).

Disqualifiers

Patients who were unable to complete scales such as headache diary.

Patients denied or unable to be admitted for long-term follow-up.

Trial population

Male or female participants ages 4 to 99 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 5 trial groups
Group A: Migraine
Group B: Other Primary Headache Disorders
Group C: Vertigo
Group D: Secondary Headache Disorders
Group E: Normal control

Trial outcomes

Primary outcomes

1

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.).

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years
2

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.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years
3

Vertigo attack

Vertigo is a sensation of feeling off balance. Vertigo attack is defined as any vertigo or dizziness attacks, such as the condition where person has the sensation of moving or of surrounding objects moving when they are not. Some questionnaires, such as the dizziness handicap inventory (DHI) and Vertigo Symptom Scale (VSS) are used to assess the severity of vertigo. The differential diagnosis of vertigo or dizziness can be narrowed with easy-to-perform physical examination tests, including evaluation for nystagmus, the Dix Hallpike maneuver, and orthostatic blood pressure testing.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years

Secondary outcomes

1

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.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years
2

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.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years
3

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.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years
4

Cumulative Hours of Moderate / Severe Pain

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.

Time frame
Medium term: within 6 months after initial diagnosis; long term: 30 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Zhejiang University

Collaborator

Tiantai County People's Hospital

Collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

Huzhou Central Hospital

Collaborator

The Affiliated Hospital of Hangzhou Normal University

Collaborator

Xin Hua Hospital of Zhejiang Province

Collaborator

The First People's Hospital of Huzhou

Collaborator

Zhongshan 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

Jiaxing Hospital of T.C.M

Collaborator

Shaoxing People's Hospital

Collaborator

The First People Hospital of Hangzhou Lin An District

Collaborator

The People's Hospital of Quzhou

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

First People's Hospital of Hangzhou

Collaborator

SIR RUNRUN Hospital

Collaborator