China Headache and Vertigo Registry Study

NCT04939922 | Recruiting DMC

• 1 other identifier: 2021-0283
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Disorders, Primary; Headache Disorders, Secondary; Migraine; Tension-Type Headache; Cluster Headache; Vertigo, Constant; 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: 30 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: 30 years

• 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.

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

Secondary Outcomes (28)

• Migraine Attack

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

• 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: 30 years

• Headache Intensity

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

• Cumulative Hours of Moderate / Severe Pain

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

• Days Without Symptoms

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

• 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).

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
• Tiantai People 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

Study Sites (1)

Kaiming Liu

Hangzhou, Zhejiang, 370001, China

RECRUITING

Related Publications (3)

• Zou X, He J, Zhou M, Zhao F, Tian X, Xu X, Hong W, Wang F, Chen J, Qin C, Xia J, Xie Y, Xiao Y, Liu K, Guo L. Photophobia and Visual Triggers in Vestibular Migraine. Neurol Ther. 2024 Aug;13(4):1191-1201. doi: 10.1007/s40120-024-00631-8. Epub 2024 May 31.

  PMID: 38819614 DERIVED

• Xu X, Zhou M, Wu X, Zhao F, Luo X, Li K, Zeng Q, He J, Cheng H, Guan X, Huang P, Zhang M, Liu K. Increased iron deposition in nucleus accumbens associated with disease progression and chronicity in migraine. BMC Med. 2023 Apr 7;21(1):136. doi: 10.1186/s12916-023-02855-1.

  PMID: 37024948 DERIVED

• Liu K, Tian X, Hong W, Xiao Y, Chen J, Jin H, Wang F, Xu X, Zang T, Zhang L, Pan M, Zou X. Positive Relationship Between Paroxysmal Vertigo and Right-to-Left Shunt: A Large Observational Study. Front Neurol. 2022 Jun 3;13:927853. doi: 10.3389/fneur.2022.927853. eCollection 2022.

  PMID: 35720061 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias; 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: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 25, 2021
• Study Start: June 12, 2017
• Primary Completion (Estimated): December 12, 2050
• Study Completion (Estimated): December 12, 2050
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)