International Headache Registry Study

Fibromyalgia Clinical Trial

— IHRS  

Official title:

International Headache and Vertigo Registration Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418218
• Other study ID #: 20220430
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: December 31, 2082

Study information

• Verified date: October 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Kaiming Liu, Doctor
• Phone: +8615068862055
• Email: 2314411[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2082
• Est. primary completion date: December 31, 2082
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Fibromyalgia
• Headache
• Headache Disorders
• Headache Disorders, Primary
• Headache Disorders, Secondary
• Migraine
• Migraine Disorders
• Myofascial Pain Syndromes
• Tension-Type Headache
• Vertigo
• Vestibular Migraine

Locations

Country	Name	City	State
China	Kaiming Liu	Hangzhou	Zhejiang

Sponsors (25)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Affiliated Hospital of Shaoxing Wenli University, Chongqing Xinqiao Hospital, Deqing County People's Hospital, First Affiliated Hospital of Wenzhou Medical University, First People's Hospital of Hangzhou, Hangzhou Hospital of Traditional Chinese Medicine, Huizhou Municipal Central Hospital, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing No.1 Hospital, Linhai First People's Hospital, Pain Management Center, Stanford University, USA, People's Hospital of Lin 'an City, Quzhou City People's Hospital, Shaoxing People's Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Zhejiang Chinese Medical University, The First People's Hospital of Huzhou, The Fourth Affiliated Hospital of Medical College of Zhejiang University, The Second Affiliated Hospital of Jiaxing University, Tiantai People's Hospital, Wenling First People's Hospital, Xin Hua Hospital of Zhejiang Province, Zhejiang University, Zhongshan Hospital Of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	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.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Cumulative Hours of Moderate / Severe Pain at 28 Days	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.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Days Without Symptoms	Defined as the number of days without aura, prodromal symptoms, headaches and subsequent symptoms. It needs to be determined by headache diary.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Days Without Headache	The number of days without headache also includes the number of days without related symptoms directly caused by migraine (including physical function, cognitive or emotional disorders).	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Peak Headache Pain Intensity	Subjects should record the maximum intensity of daily headaches and any medication used. An 11-point digital rating scale can be used instead of or in conjunction with a 4-level classified rating scale.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Migraine Disability Assessment (MIDAS)	MIDAS is a seven-item questionnaire designed to quantify headache-related disability within 3 months. The MIDAS score is the sum of days of absenteeism or absenteeism caused by headache, days of work or school plus days of housework, days without housework and days without non-work activities caused by headache in the last 3 months.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Headache Impact Scale (HIT-6)	HIT-6 is a six-question assessment scale used to assess the effects of headache on subjects' ability to work, school, housework and social tasks. The scale assessed the effects of headache on daily life and the functional ability of the subjects. The answer to the evaluation scale is based on the frequency of use of the 5-point scale from "never" to "often". The total score of HIT-6 ranges from 36 to 78, which is the sum of the scores between 6 (never) and 13 (often) for each question.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Migraine Specific Quality of Life Questionnaire (MSQV2.1)	MSQV2.1 is a 14-item questionnaire used to assess health-related quality of life decline due to migraine in the last 4 weeks. The questionnaire is divided into three areas: the role function limitation area, which is used to assess how migraine restricts the daily social and work-related activities of migraine patients; the role function block area, which is used to assess how migraine prevents these activities; and the emotional function area, which is used to evaluate the emotions associated with migraine. The subjects answered these items using a six-component scale from "never" to "at any time". The original dimension score was calculated by the sum of item answer scores and converted back to 0 to 100. The higher the score, the better the quality of life.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Patient Health Questionnaire (PHQ-9)	PHQ-9 is a validated, self-administered, concise tool for screening and diagnosis of mental health disorders, which has been tested in office practice. The screening scale is easy to use and can be completed in a short time, which improves the recognition rate of depression and facilitates the diagnosis and treatment of depression. PHQ-9 consists of 9 DSM-? diagnostic criteria for depression in the last 2 weeks. Subjects were asked to use a 4-component scale to indicate the frequency of 9 depressive symptoms in the last 2 weeks: 0 (none at all), 1 (a few days), 2 (more than half) and 3 (almost every day). The total score ranges from 0 to 27 (from the best to the worst). A score of 15 to 19 indicates moderate to severe depression and a score of 20 to 27 indicates severe depression.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Generalized Anxiety Disorder (GAD-7)	GAD-7 is a proven, self-administered and concise tool for screening and diagnosing mental health disorders, which has been tested in the field in office practice. The screening scale is easy to use and can be completed in a short time, which improves the recognition rate of anxiety disorders and facilitates diagnosis and treatment. The main statistical index of this scale is the total score, that is, the sum of item scores. The total score range of GAD-7 is 0: 21 and that of GAD-2 is 0: 6. The score of GAD-7 can be used to evaluate the severity of anxiety symptoms: 0: 4: no clinical significance: anxiety: 5: 9: mild; 10: 14: moderate; > 15: severe. When used as an assistant diagnosis of anxiety symptoms, the cut-off value of GAD-7 is greater than or equal to 10.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Functional Impairment Scale (FIS)	Functional impairment scale (FIS) is a 4-point scale to evaluate the functional status and injury intensity in daily activities. It can be used in conjunction with the four-point pain intensity scale, usually done daily and summarized within four weeks.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Euroqol-5 Dimension Questionnaire (EQ-5D)	EQ-5D-5Lis a general tool for assessing health status. EQ-5D-5Lconsists of two parts of EQ-5D description system and EQ VAS. The description system consists of five dimensions (activity ability, self-care, daily activities, pain / discomfort and anxiety / depression). Respondents need to tick (or cross) the corresponding boxes of the most appropriate declaration for each of the five dimensions to indicate their health status. The score of the EQ-5D description system generally ranges from 0 (death) to 1 (completely healthy). EQ VAS recorded the respondents' self-rated health outcomes through a vertical visual simulation scale, and the two endpoints were "imaginable ideal health state" and "imaginable least ideal health state". EQ VAS scores range from 0 (the least ideal state of health imaginable) to 100 (the most ideal state of health imaginable).	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Suicidal Ideation Score (C-SSRS Scale)	Suicidal ideation should be monitored in trials of central action drugs, higher scores mean a worse outcome.; Many migraine clinical trials used the Columbia suicide severity scale (C SSRS).The C-SSRS consists of a maximum of 20 items. C-SSRS will be administered in study subjects at each study visit to assess possible suicidal ideation and behavior. Reports of suicidal ideation with intent to act (endorse item 4 or 5) and reports of actual, aborted, or interrupted suicide attempts or a behavior preparatory for making an attempt indicate subjects at high risk for suicide.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Pulse Rate	Pulse rate will be measured during the visit.It means the number of heartbeats per minute, calculated with a stopwatch.Under normal circumstances, the pulse rate is consistent with the heart rate, and the normal range is 60-100 beats per minute. If it is greater than 100 beats per minute, it is called tachycardia. If it is less than 60 beats per minute, it is called bradycardia.; Record whether the pulse rate is normal, and describe in detail if abnormal. Record the number of people with clinically significant abnormal pulse rate.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Respiratory Rate	Respiratory rate will be measured during the visit.It means the number of breaths per minute, calculated with a stopwatch.Clinically, one inhalation and one exhalation are defined as one breath. The normal breathing rate is 12-20 breaths per minute.; Record whether the respiratory rate is normal, and describe in detail if abnormal.; Record the number of people with clinically significant abnormal respiratory rate.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Blood Pressure	Blood Pressure will be measured during the visit,including systolic blood pressure(SBP) and diastolic blood pressure(DBP). It can be calculated with a sphygmomanometer.; Blood pressure level classification for adults over 18 years old: normal blood pressure (SBP<120 mmHg and DBP<80 mmHg), high normal value [SBP 120-139 mmHg and (or) DBP 80-89 mmHg], hypertension [SBP=140 mmHg] and (or) DBP=90 mmHg].; Record whether the blood pressure is normal, and describe in detail if abnormal.; Record the number of people with clinically significant abnormal blood pressure.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Body Temperature	Body temperature will be measured during the visit.It can be calculated with a thermometer.The normal armpit body temperature of an average adult is 36-37°C.; Record whether the body temperature is normal, and describe in detail if abnormal.; Record the number of people with clinically significant abnormal body temperature.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Body Mass Index (BMI)	The following measurements are to be performed: height (initial screening only) and weight. Height and weight are to be measured without shoes. Body Mass Index (BMI) should be calculated using the following formula: BMI (kg/m2= weight (kg)/[height (cm)/100]2.; A normal BMI is between 20 and 25, over 25 is overweight and over 30 is obese.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Magnetic Resonance Imaging(MRI) T1	Patients will accept MRI scans. MRI T1 imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	MRI T2	Patients will accept MRI scans. MRI T2 imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	MRI T2 FLIAR	Patients will accept MRI scans. MRI T2 FLIAR imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Susceptibility weighted imaging(SWI) in MRI	Patients will accept MRI scans. SWI imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Arterial spin labeling(ASL) in MRI	Patients will accept MRI scans. ASL imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Diffusion Tensor Imaging(DTI) in MRI	Patients will accept MRI scans. DTI imaging data and description given by professional radiologist will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years
Secondary	Echocardiography	Patients will accept Echocardiography. The degree of Right-to-left Shunt will be collected.	Medium term: within 6 months after initial diagnosis; long term: 60 years