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

Wei Dai

Status: Enrolling

Conditions: Migraine Disorders; Medication-overuse Headache

Treatments: Other: Phone interview

Study type: Observational

Funder types: Other

Identifiers

NCT05528081

S-2022-543-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

122 participants in 3 patient groups

Persons with migraine disease

Description:

Persons diagnosed with migraine based on the third edition of the International Classification of Headache Disorders (ICHD-3) and underwent baseline 3-tesla MRI

Treatment:

Other: Phone interview

Persons with medication-overuse headache

Description:

Persons diagnosed with MOH based on the ICHD-3 and underwent baseline 3-tesla MRI

Treatment:

Other: Phone interview

Healthy controls

Description:

Healthy individuals with no history of primary or secondary headache based on the ICHD-3 and underwent baseline 3-tesla MRI