NCT05528081

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: Wei Dai · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine Disorders
• Medication-overuse Headache

Interventions

Type	Name	Description
OTHER	Phone interview	Participants will be interviewed by phone at 3, 12, 24 months after the baseline MRI scans.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-31
• First posted: 2022-09-06
• Last updated: 2022-10-19

Locations

1 site across 1 country: China