Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
LMMM
A Longitudinal Follow-up Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
1 other identifier
observational
122
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2022
CompletedFirst Posted
Study publicly available on registry
September 6, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedOctober 19, 2022
October 1, 2022
2 years
August 20, 2022
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (45)
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.).
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.).
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.).
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.
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.
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.
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.
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.
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.
24 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
3 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
12 months after the baseline MRI
Mean Headache Duration (hours)
As a feature of the headache attack duration.
24 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
3 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
12 months after the baseline MRI
Nausea (number)
As a feature of the accompany symptoms during an attack.
24 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
3 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
12 months after the baseline MRI
Vomiting (number)
As a feature of the accompany symptoms during an attack.
24 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
3 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
12 months after the baseline MRI
Photophobia (number)
As a feature of the accompany symptoms during an attack.
24 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
3 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
12 months after the baseline MRI
Phonophobia (number)
As a feature of the accompany symptoms during an attack.
24 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
3 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
12 months after the baseline MRI
Aggravation by Movement (number)
As a feature of the accompany symptoms during an attack.
24 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
3 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
12 months after the baseline MRI
Response to Acute Treatment
To describe response to prior acute medications.
24 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
3 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
12 months after the baseline MRI
Response to Prophylactic Treatment
To describe response to prior prophylactic medications.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
24 months after the baseline MRI
Study Arms (3)
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
Persons with medication-overuse headache
Persons 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
Interventions
Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
Eligibility Criteria
Persons with migraine disease, MOH, and healthy controls who have completed baseline MRI.
You may qualify if:
- 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.
You may not qualify if:
- Refuse or unable to complete the phone interview procedure during follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wei Dailead
- International Headache Societycollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Dai, M.D.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator Wei Dai
Study Record Dates
First Submitted
August 20, 2022
First Posted
September 6, 2022
Study Start
October 1, 2022
Primary Completion
October 1, 2024
Study Completion
October 31, 2025
Last Updated
October 19, 2022
Record last verified: 2022-10