A Longitudinal Follow-up Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Mean Headache Duration (hours)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Refuse or unable to complete the phone interview procedure during follow-up.
结局指标
主要结局
Mean Headache Duration (hours)
时间窗: 24 months after the baseline MRI
As a feature of the headache attack duration.
Vomiting (number)
时间窗: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Photophobia (number)
时间窗: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Phonophobia (number)
时间窗: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Patient Health Questionnaire 9 Depression Scale Total Score
时间窗: 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
时间窗: 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)
时间窗: 24 months after the baseline MRI
As a feature of the accompany symptoms during an attack.
Response to Acute Treatment
时间窗: 24 months after the baseline MRI
To describe response to prior acute medications.
Migraine Disability Assessment Test Total Score
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 24 months after the baseline MRI
To describe response to prior prophylactic medications.
次要结局
未报告次要终点
研究者
Wei Dai
Principal Investigator Wei Dai
Chinese PLA General Hospital