Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
- Conditions
- Medication-overuse HeadacheMigraine Disorders
- Interventions
- Other: Phone interview
- Registration Number
- NCT05528081
- Lead Sponsor
- Wei Dai
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- 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.
- Refuse or unable to complete the phone interview procedure during follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Persons with migraine disease Phone interview 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 Phone interview Persons diagnosed with MOH based on the ICHD-3 and underwent baseline 3-tesla MRI
- Primary Outcome Measures
Name Time Method Mean Headache Duration (hours) 24 months after the baseline MRI As a feature of the headache attack duration.
Vomiting (number) 24 months after the baseline MRI As a feature of the accompany symptoms during an attack.
Photophobia (number) 24 months after the baseline MRI As a feature of the accompany symptoms during an attack.
Phonophobia (number) 24 months after the baseline MRI As a feature of the accompany symptoms during an attack.
Patient Health Questionnaire 9 Depression Scale Total Score 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 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.
Nausea (number) 24 months after the baseline MRI As a feature of the accompany symptoms during an attack.
Response to Acute Treatment 24 months after the baseline MRI To describe response to prior acute medications.
Migraine Disability Assessment Test Total Score 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.
Monthly Number of Migraine Days 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 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.
Aggravation by Movement (number) 24 months after the baseline MRI As a feature of the accompany symptoms during an attack.
Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score 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.
Severity of Headache Measured by Visual Analogue Scale 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.
Response to Prophylactic Treatment 24 months after the baseline MRI To describe response to prior prophylactic medications.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China