Clinical trial NCT04939922: China Headache Registry Study
Official title: China Headache and Vertigo Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Tiantai People Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Huzhou Central Hospital
name: The Affiliated Hospital of Hangzhou Normal University
name: Xin Hua Hospital of Zhejiang Province
name: The First People's Hospital of Huzhou
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: First Affiliated Hospital of Wenzhou Medical University
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Hangzhou Hospital of Traditional Chinese Medicine
name: Jiaxing Hospital of T.C.M
name: The First Hospital of Jia Xing
name: Shaoxing People's Hospital
name: The First People Hospital of Hangzhou Lin An District
name: The First People's Hospital of Hangzhou
name: The People's Hospital of Quzhou
First posted: 2021-06-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female participants ages 4 to 99 years

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.

Detailed description: 1. Research contents:

   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.
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.
3. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. GCP training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)

   / independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial. In order to meet the audit and / or inspection requirements of the regulator

   , the researcher / institution must agree to keep the relevant records, including the identification numbers of all subjects (sufficient information is linked to the records, such as eCRF and hospital records), all originally signed informed consent forms. All eCRF copies, safety report forms, original records, treatment details, related communication documents (such as letters, meeting minutes, phone reports). Researchers / institutions are required to keep records in accordance with relevant specifications.

   Relevant Chinese regulations and research institutions' requirements for the protection of subjects' personal information. Authorized representatives and regulatory agencies to examine (and copy if permitted by law) clinical records for quality review, inspection, and evaluation of safety, research progress and data validity. Raw data is all the information necessary to reconstruct and evaluate clinical research and is the original record of clinical findings, observations or other activities. Examples of these original documents and data records include, but are not limited to: hospital records, laboratory records, memos, subject diary cards, pharmacy dispensing records, audio recordings of consultation meetings, automated instrument records, verified as accurate and complete copies or transcripts, microfilm, photographic negatives, microfilms or disks, x-rays and stored in pharmacies participating in the study, documents and records of subjects in laboratories and medical technology departments.
4. Statistical analysis plan Differences between the two groups will be tested using the Mann-Whitney U test. P \<0.05 indicates a significant difference. SPSS will be used. All statistical analyses will be based on the intent-to-treat principle using the full analysis set.

Eligibility criteria: Inclusion Criteria:

* 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).

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.

Primary outcomes:
measure: Days of Migraine
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Moderate / Severe Headache Days
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Vertigo attack
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
Secondary outcomes:
measure: Migraine Attack
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Headache Intensity
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Cumulative Hours of Moderate / Severe Pain
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Days Without Symptoms
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Days Without Headache
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Peak Headache Pain Intensity
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Acute Medication Use Day
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Activity Impairment in Migraine - Diary (AIM-D)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Patient Difficulty in Concentrating, Difficulty in Thinking Clearly, Activity Level, and Activity Limitation
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Headache Impact Test (HIT-6)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Migraine Disability Assessment (MIDAS)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Patient Global Impression of Change (PGIC)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Work Productivity and Activity Impairment Questionnaire Migraine V2.0 (WPAI:MIGRAINE)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: European Quality of Life - 5 Dimensional (EQ-5D-5L)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Patient Global Impression - Severity (PGI-S)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Patient-Reported Outcomes Measurement Information System Pain Interference - Short Form 6a (PROMIS-PI)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Functional Impairment Scale (FIS)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Migraine Physiological Function Influence Diary (MPFID)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Biomarkers of primary headache and vertigo
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Safety Measures, Adverse Events and Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Physical Examination
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Medical and Medication History
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Physical Measurements
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
measure: Genetic analysis of familial headache and vertigo
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 30 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Kaiming Liu
state: Zhejiang
Study officials:
affiliation: headache specialist clinic of the Second Affiliated Hospital of Zhejiang Medical University
name: Kaiming Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.