Clinical trial NCT05418218: International Headache Registry Study
Official title: International Headache and Vertigo Registration Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache Disorders, Primary
Headache Disorders, Secondary
Migraine
Tension-Type Headache
Vertigo
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: First People's Hospital of Hangzhou
name: Affiliated Hospital of Shaoxing Wenli University
name: Tiantai People's Hospital
name: People's Hospital of Lin 'an City
name: Deqing County People's Hospital
name: Jiaxing No.1 Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Shaoxing People's Hospital
name: Huzhou Central Hospital
name: The Affiliated Hospital of Hangzhou Normal University
name: Quzhou City People's Hospital
name: Xin Hua Hospital of Zhejiang Province
name: The First People's Hospital of Huzhou
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: Jiaxing 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: Linhai First People's Hospital
name: Pain Management Center, Stanford University, USA
name: The Second Affiliated Hospital of Jiaxing University
name: The Fourth Affiliated Hospital of Medical College of Zhejiang University
name: Chongqing Xinqiao Hospital
First posted: 2022-06-14
Enrollment: 200000
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 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.

Detailed description: 1. Research contents:

   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.
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.

Eligibility criteria: Inclusion Criteria:

The following are requirements for entry into the study:

1. 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.
2. Male or female participants ages 4 to 99 years, inclusive, at Visit 1.
3. 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).

Exclusion Criteria:

1. Patients who were unable to complete scales such as headache diary.
2. 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: 60 years
measure: Moderate / Severe Headache Days
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Migraine Attack
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary outcomes:
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: 60 years
measure: Headache Intensity
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Cumulative Hours of Moderate / Severe Pain at 28 Days
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Days Without Symptoms
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Days Without Headache
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Peak Headache Pain Intensity
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Migraine Disability Assessment (MIDAS)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Headache Impact Scale (HIT-6)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Migraine Specific Quality of Life Questionnaire (MSQV2.1)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Functional Impairment Scale (FIS)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Euroqol-5 Dimension Questionnaire (EQ-5D)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Suicidal Ideation Score (C-SSRS Scale)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Pulse Rate
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Respiratory Rate
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Blood Pressure
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Body Temperature
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Body Mass Index (BMI)
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Magnetic Resonance Imaging(MRI) T1
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: MRI T2
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: MRI T2 FLIAR
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Susceptibility weighted imaging(SWI) in MRI
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Arterial spin labeling(ASL) in MRI
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Diffusion Tensor Imaging(DTI) in MRI
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 years
measure: Echocardiography
timeFrame: Medium term: within 6 months after initial diagnosis; long term: 60 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: