International Headache Registry Study

NCT05418218 | Recruiting DMC

• 1 other identifier: 20220430
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Disorders, Primary; Headache Disorders, Secondary; Migraine; Tension-Type Headache; Vertigo; Vestibular Migraine; Fibromyalgia

Keywords

Migraine; Headache Disorders; Vertigo; Vestibular Migraine; Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• 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.).

  Medium term: within 6 months after initial diagnosis; long term: 60 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 (triptan ergot / other), and response to treatment should also be recorded.

  Medium term: within 6 months after initial diagnosis; long term: 60 years

• 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.

  Medium term: within 6 months after initial diagnosis; long term: 60 years

Secondary Outcomes (26)

• The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks

  Medium term: within 6 months after initial diagnosis; long term: 60 years

• Headache Intensity

  Medium term: within 6 months after initial diagnosis; long term: 60 years

• Cumulative Hours of Moderate / Severe Pain at 28 Days

  Medium term: within 6 months after initial diagnosis; long term: 60 years

• Days Without Symptoms

  Medium term: within 6 months after initial diagnosis; long term: 60 years

• Days Without Headache

  Medium term: within 6 months after initial diagnosis; long term: 60 years

Study Arms (5)

Migraine

Patients with migraine (including vestibular migraine), including all types of migraine as defined by ICHD-3.

Other Primary Headache Disorders

Patients with other primary headache disorders (excluding migraine), including all types of other primary headache disorders (such as Tension-Type Headache, Cluster Headache) as defined by ICHD-3.

Vertigo

Patients with other vertigo disorders (excluding vestibular migraine).

Secondary Headache Disorders

Patients with secondary headache disorders as defined by ICHD-3.

Normal control

Normal people do not have headache and vertigo.

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female participants ages 4 to 99 years

You may qualify if:

• 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).

You may not qualify if:

• Patients who were unable to complete scales such as headache diary.
• Patients denied or unable to be admitted for long-term follow-up.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Affiliated Hospital of Shaoxing Wenli University: collaborator
• Tiantai 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

Study Sites (1)

Kaiming Liu

Hangzhou, Zhejiang, 370001, China

RECRUITING

MeSH Terms

Conditions

Headache Disorders, Primary; Headache Disorders, Secondary; Migraine Disorders; Tension-Type Headache; Vertigo; Fibromyalgia; Headache Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Study Officials

• Kaiming Liu, Doctor

  headache specialist clinic of the Second Affiliated Hospital of Zhejiang Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiming Liu, Doctor

CONTACT

+8615068862055; 2314411@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: June 14, 2022
• Study Start: July 12, 2021
• Primary Completion (Estimated): December 31, 2082
• Study Completion (Estimated): December 31, 2082
• Last Updated: May 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)