Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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

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Migraine Disorders Medication-overuse Headache

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Phone interview

Intervention Type OTHER

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

Phone interview

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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Phone interview

Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.

Intervention Type OTHER

Eligibility Criteria

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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.