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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine Disorders; Medication-overuse Headache
• Intervention / Treatment: Other: Phone interview

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 Type: Observational
• Enrollment (Anticipated): 122

Contacts and Locations

• Study Contact: Name: Wei Dai, M.D.; Phone Number: 0086-01066937757; Email: daiwei918918@plagh.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Wei Dai, M.D.; Phone Number: 0086-01066937757; Email: daiwei918918@plagh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Persons with migraine disease, MOH, and healthy controls who have completed baseline MRI.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Refuse or unable to complete the phone interview procedure during follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Phone interview; Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
Persons with medication-overuse headache; Persons diagnosed with MOH based on the ICHD-3 and underwent baseline 3-tesla MRI	Other: Phone interview; Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wei Dai
• Collaborators: International Headache Society
• Investigators: Principal Investigator: Wei Dai, M.D., Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Migraine; Medication-overuse Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Headache Disorders, Secondary
• Other Study ID Numbers: S-2022-543-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No