International Headache Registry Study

Browse trials for

• Headache Disorders, Primary 42
• Headache Disorders, Secondary 52
• Migraine Disorders 1,657
• Tension-Type Headache 143
• Vertigo 187
• Fibromyalgia 1,243

Keywords

• Migraine
• Headache Disorders
• Vertigo
• Vestibular Migraine
• Fibromyalgia

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's planned enrollment of 200,000 is above the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Study population

Groups and cohorts

• 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.

Primary outcomes

1. 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.).

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

2. 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.

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

3. 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.

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

Secondary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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).

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

6. 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.

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

7. 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.

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

8. 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.

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

9. 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.

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

10. 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-Ⅳ 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.

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

11. 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.

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

12. 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.

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

13. 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).

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

14. 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.

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

15. 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.

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

16. 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.

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

17. 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.

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

18. 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.

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

19. 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.

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

20. Magnetic Resonance Imaging(MRI) T1

    Patients will accept MRI scans. MRI T1 imaging data and description given by professional radiologist will be collected.

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

21. MRI T2

    Patients will accept MRI scans. MRI T2 imaging data and description given by professional radiologist will be collected.

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

22. MRI T2 FLIAR

    Patients will accept MRI scans. MRI T2 FLIAR imaging data and description given by professional radiologist will be collected.

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

23. Susceptibility weighted imaging(SWI) in MRI

    Patients will accept MRI scans. SWI imaging data and description given by professional radiologist will be collected.

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

24. Arterial spin labeling(ASL) in MRI

    Patients will accept MRI scans. ASL imaging data and description given by professional radiologist will be collected.

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

25. Diffusion Tensor Imaging(DTI) in MRI

    Patients will accept MRI scans. DTI imaging data and description given by professional radiologist will be collected.

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

26. Echocardiography

    Patients will accept Echocardiography. The degree of Right-to-left Shunt will be collected.

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

Individual participant data

Plan to share: No