Migraine DisordersLMMMNCT05528081
Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
An observational study of Migraine Disorders and Medication-overuse Headache, run by Wei Dai at 1 site in China.
Trial summary
This is a phone interview research study for patients with migraine or medication-overuse headache (MOH) who have completed baseline MRI scans. Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Medication-overuse Headache
- What is being tested?
- Phone interview
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with migraine disease, MOH, and healthy controls who have completed baseline MRI.
Who may be able to join
- Participants who are diagnosed with migraine or MOH at baseline visit, signed the consent form, and completed MRI scans.
- Participants who are willing to take the phone interview during follow-up.
Who cannot join
- Refuse or unable to complete the phone interview procedure during follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Wei Dai, M.D., 0086-01066937757, daiwei918918@plagh.org
About this study
Official title: A Longitudinal Follow-up Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
This is a phone interview research study for patients with migraine or medication-overuse headache (MOH) who have completed baseline MRI scans. Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
The purpose of this study is to potentially identify the baseline brain functional or structural signatures (functional connectivity, regional homogeneity, amplitude of low frequency fluctuation, and so such) that are predictive of the short- and long- term outcomes as well as treatment response of migraine and MOH patients.
Read the detailed description
Participants have been administered informed consent, taken medical history and performed a physical examination, and completed MRI scans at baseline visit. This study only comprises the follow-up research procedure.
After the MRI scans, all included patients were treated at the headache center by headache specialists according to their clinical experience. The follow-up time points will be 3 months, 12 months, 24 months after baseline MRI scans. The investigator will interview the patients by telephone to assess their headache features (duration, frequency, severity, accompany symptoms, migraine days per months, moderate to severe headache days per month, medications being used…) and Patient Health Questionnaire 9 Depression Scale (PHQ-9), Generalized Anxiety Disorder Assessment 7-item Scale (GAD-7), quality and patterns of sleep using Pittsburgh Sleep Quality Index (PSQI), and functional disability caused by migraine using the Migraine Disability Assessment Scale (MIDAS) within the last 10 days at each time point.
- Conditions
- Migraine Disorders, Medication-overuse Headache
- Being tested
- Phone interview
- Keywords
- Migraine, Medication-overuse Headache, MRI
- Medical subject headings
- Migraine Disorders, Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewOther
Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
| Study group | Role | What they receive |
|---|---|---|
| Persons with migraine disease | Persons diagnosed with migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) and underwent baseline 3-tesla MRI Receives: Other: Phone interview | |
| Persons with medication-overuse headache | Persons diagnosed with MOH based on the ICHD-3 and underwent baseline 3-tesla MRI Receives: Other: Phone interview | |
| Healthy controls | Healthy individuals with no history of primary or secondary headache based on the ICHD-3 and underwent baseline 3-tesla MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Number of Migraine Days
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Measured: 3 months after the baseline MRI
Monthly Number of Migraine Days
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Measured: 12 months after the baseline MRI
Monthly Number of Migraine Days
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Measured: 24 months after the baseline MRI
Monthly Number of Moderate/Severe Headache Days
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Measured: 3 months after the baseline MRI
Monthly Number of Moderate/Severe Headache Days
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Measured: 12 months after the baseline MRI
Monthly Number of Moderate/Severe Headache Days
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Measured: 24 months after the baseline MRI
Severity of Headache Measured by Visual Analogue Scale
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Measured: 3 months after the baseline MRI
Severity of Headache Measured by Visual Analogue Scale
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Measured: 12 months after the baseline MRI
Severity of Headache Measured by Visual Analogue Scale
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Measured: 24 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
Measured: 3 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
Measured: 12 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
Measured: 24 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
Measured: 3 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
Measured: 12 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
Measured: 24 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
Measured: 3 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
Measured: 12 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
Measured: 24 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 3 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 12 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 24 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 3 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 12 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
Measured: 24 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
Measured: 3 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
Measured: 12 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
Measured: 24 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
Measured: 3 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
Measured: 12 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
Measured: 24 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
Measured: 3 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
Measured: 12 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
Measured: 24 months after the baseline MRI
Migraine Disability Assessment Test Total Score
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Measured: 3 months after the baseline MRI
Migraine Disability Assessment Test Total Score
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Measured: 12 months after the baseline MRI
Migraine Disability Assessment Test Total Score
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Measured: 24 months after the baseline MRI
Patient Health Questionnaire 9 Depression Scale Total Score
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Measured: 3 months after the baseline MRI
Patient Health Questionnaire 9 Depression Scale Total Score
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Measured: 12 months after the baseline MRI
Patient Health Questionnaire 9 Depression Scale Total Score
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Measured: 24 months after the baseline MRI
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Measured: 3 months after the baseline MRI
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Measured: 12 months after the baseline MRI
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Measured: 24 months after the baseline MRI
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 3 months after the baseline MRI
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 12 months after the baseline MRI
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 24 months after the baseline MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Dai
- Sponsor type
- University, hospital or other
- Collaborators
- International Headache Society
- Responsible party
- Sponsor-investigator, Wei Dai, Chinese PLA General Hospital
- Investigators
- Wei Dai, M.D., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528081
- Sponsor's protocol ID
- S-2022-543-01
- Acronym
- LMMM
- Status last verified
- Oct 2022
- First submitted
- 20 Aug 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Follow-up Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
- ClinicalTrials.gov ID
- NCT05528081
- Acronym / sponsor ID
- LMMM / S-2022-543-01
- Conditions
- Migraine Disorders, Medication-overuse Headache
- Keywords
- Migraine, Medication-overuse Headache, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Wei DaiUniversity, hospital or other
- Collaborators
- International Headache Society
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phone interview research study for patients with migraine or medication-overuse headache (MOH) who have completed baseline MRI scans. Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
The purpose of this study is to potentially identify the baseline brain functional or structural signatures (functional connectivity, regional homogeneity, amplitude of low frequency fluctuation, and so such) that are predictive of the short- and long- term outcomes as well as treatment response of migraine and MOH patients.
Detailed description
Participants have been administered informed consent, taken medical history and performed a physical examination, and completed MRI scans at baseline visit. This study only comprises the follow-up research procedure.
After the MRI scans, all included patients were treated at the headache center by headache specialists according to their clinical experience. The follow-up time points will be 3 months, 12 months, 24 months after baseline MRI scans. The investigator will interview the patients by telephone to assess their headache features (duration, frequency, severity, accompany symptoms, migraine days per months, moderate to severe headache days per month, medications being used…) and Patient Health Questionnaire 9 Depression Scale (PHQ-9), Generalized Anxiety Disorder Assessment 7-item Scale (GAD-7), quality and patterns of sleep using Pittsburgh Sleep Quality Index (PSQI), and functional disability caused by migraine using the Migraine Disability Assessment Scale (MIDAS) within the last 10 days at each time point.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Persons with migraine disease | – | Other: Phone interviewPersons diagnosed with migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) and underwent baseline 3-tesla MRI |
| Persons with medication-overuse headache | – | Other: Phone interviewPersons diagnosed with MOH based on the ICHD-3 and underwent baseline 3-tesla MRI |
| Healthy controls | – | –Healthy individuals with no history of primary or secondary headache based on the ICHD-3 and underwent baseline 3-tesla MRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with migraine disease, MOH, and healthy controls who have completed baseline MRI.
Key inclusion criteria (2 listed)
- Participants who are diagnosed with migraine or MOH at baseline visit, signed the consent form, and completed MRI scans.
- Participants who are willing to take the phone interview during follow-up.
Key exclusion criteria (1 listed)
- Refuse or unable to complete the phone interview procedure during follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone interviewParticipants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans. | Other | Persons with medication-overuse headache, Persons with migraine disease |
Primary outcome
Monthly Number of Migraine Days
Time frame: 3 months after the baseline MRI
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Monthly Number of Migraine Days
Time frame: 12 months after the baseline MRI
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Monthly Number of Migraine Days
Time frame: 24 months after the baseline MRI
A migraine day is defined as a day with headache lasting at least 30 minutes without intake of analgesics and meeting ICHD-3 criteria for migraine or probable migraine. A migraine day may also be defined as a day with headache that successfully responds to acute treatment with a migraine-specific medication (triptan, ditan, gepant, ergotamine, etc.).
Monthly Number of Moderate/Severe Headache Days
Time frame: 3 months after the baseline MRI
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Monthly Number of Moderate/Severe Headache Days
Time frame: 12 months after the baseline MRI
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Monthly Number of Moderate/Severe Headache Days
Time frame: 24 months after the baseline MRI
A moderate/severe headache day is defined as a day with headache pain of moderate or severe intensity that lasts at least 4 hours without medication, or a day with a headache pain of at least moderate intensity that responds to acute treatment with a migraine-specific medication.
Severity of Headache Measured by Visual Analogue Scale
Time frame: 3 months after the baseline MRI
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Severity of Headache Measured by Visual Analogue Scale
Time frame: 12 months after the baseline MRI
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Severity of Headache Measured by Visual Analogue Scale
Time frame: 24 months after the baseline MRI
Severity of headache is measured by VAS ranging from 0 to 10 with 1 = most mild to 10 = most severe. The mean severity of headache for each month will be calculated as: sum of severity of headache days divided by number of headache days.
Mean Headache Duration (hours)
Time frame: 3 months after the baseline MRI
As a feature of the headache attack duration.
Mean Headache Duration (hours)
Time frame: 12 months after the baseline MRI
As a feature of the headache attack duration.
Mean Headache Duration (hours)
Time frame: 24 months after the baseline MRI
As a feature of the headache attack duration.
Nausea (number)
Time frame: 3 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Nausea (number)
Time frame: 12 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Nausea (number)
Time frame: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Vomiting (number)
Time frame: 3 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Vomiting (number)
Time frame: 12 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Vomiting (number)
Time frame: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Photophobia (number)
Time frame: 3 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Photophobia (number)
Time frame: 12 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Photophobia (number)
Time frame: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Phonophobia (number)
Time frame: 3 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Phonophobia (number)
Time frame: 12 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Phonophobia (number)
Time frame: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Aggravation by Movement (number)
Time frame: 3 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Aggravation by Movement (number)
Time frame: 12 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Aggravation by Movement (number)
Time frame: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Response to Acute Treatment
Time frame: 3 months after the baseline MRI
To describe response to prior acute medications.
Response to Acute Treatment
Time frame: 12 months after the baseline MRI
To describe response to prior acute medications.
Response to Acute Treatment
Time frame: 24 months after the baseline MRI
To describe response to prior acute medications.
Response to Prophylactic Treatment
Time frame: 3 months after the baseline MRI
To describe response to prior prophylactic medications.
Response to Prophylactic Treatment
Time frame: 12 months after the baseline MRI
To describe response to prior prophylactic medications.
Response to Prophylactic Treatment
Time frame: 24 months after the baseline MRI
To describe response to prior prophylactic medications.
Migraine Disability Assessment Test Total Score
Time frame: 3 months after the baseline MRI
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Migraine Disability Assessment Test Total Score
Time frame: 12 months after the baseline MRI
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Migraine Disability Assessment Test Total Score
Time frame: 24 months after the baseline MRI
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on patients' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability.
Patient Health Questionnaire 9 Depression Scale Total Score
Time frame: 3 months after the baseline MRI
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Patient Health Questionnaire 9 Depression Scale Total Score
Time frame: 12 months after the baseline MRI
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Patient Health Questionnaire 9 Depression Scale Total Score
Time frame: 24 months after the baseline MRI
The PHQ-9 was designed to identify signs or symptoms of depression over a two-week period. The total score is calculated and can range from zero to 27. Scores of 5, 10, 15, and 20 are taken as the cut-off points for mild, moderate, moderate to severe, and severe depression, respectively.
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
Time frame: 3 months after the baseline MRI
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
Time frame: 12 months after the baseline MRI
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Generalized Anxiety Disorder Assessment 7-item Scale Total Score
Time frame: 24 months after the baseline MRI
The GAD-7 was designed to identify signs or symptoms of anxiety over a two-week period. The total score is calculated and can range from zero to 21. Scores of 5, 10, 14, and 19 are taken as the cut-off points for mild, moderate, moderate to severe, and severe anxiety, respectively.
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
Time frame: 3 months after the baseline MRI
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
Time frame: 12 months after the baseline MRI
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
Time frame: 24 months after the baseline MRI
The PSQI is to assess sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for the seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Dai, M.D. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Medication-overuse Headache, run by Wei Dai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Dai, M.D. (0086-01066937757, daiwei918918@plagh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Number of Migraine Days (time frame: 3 months after the baseline MRI). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.