Clinical trial NCT05528081: Longitudinal Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
Official title: A Longitudinal Follow-up Study of the Patients With Medication-overuse Headache or Migraine That Completed Baseline MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine Disorders
Medication-overuse Headache
Keywords: Migraine
Medication-overuse Headache
MRI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: International Headache Society
First posted: 2022-09-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with migraine disease, MOH, and healthy controls who have completed baseline MRI.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monthly Number of Migraine Days
timeFrame: 3 months after the baseline MRI
measure: Monthly Number of Migraine Days
timeFrame: 12 months after the baseline MRI
measure: Monthly Number of Migraine Days
timeFrame: 24 months after the baseline MRI
measure: Monthly Number of Moderate/Severe Headache Days
timeFrame: 3 months after the baseline MRI
measure: Monthly Number of Moderate/Severe Headache Days
timeFrame: 12 months after the baseline MRI
measure: Monthly Number of Moderate/Severe Headache Days
timeFrame: 24 months after the baseline MRI
measure: Severity of Headache Measured by Visual Analogue Scale
timeFrame: 3 months after the baseline MRI
measure: Severity of Headache Measured by Visual Analogue Scale
timeFrame: 12 months after the baseline MRI
measure: Severity of Headache Measured by Visual Analogue Scale
timeFrame: 24 months after the baseline MRI
measure: Mean Headache Duration (hours)
timeFrame: 3 months after the baseline MRI
measure: Mean Headache Duration (hours)
timeFrame: 12 months after the baseline MRI
measure: Mean Headache Duration (hours)
timeFrame: 24 months after the baseline MRI
measure: Nausea (number)
timeFrame: 3 months after the baseline MRI
measure: Nausea (number)
timeFrame: 12 months after the baseline MRI
measure: Nausea (number)
timeFrame: 24 months after the baseline MRI
measure: Vomiting (number)
timeFrame: 3 months after the baseline MRI
measure: Vomiting (number)
timeFrame: 12 months after the baseline MRI
measure: Vomiting (number)
timeFrame: 24 months after the baseline MRI
measure: Photophobia (number)
timeFrame: 3 months after the baseline MRI
measure: Photophobia (number)
timeFrame: 12 months after the baseline MRI
measure: Photophobia (number)
timeFrame: 24 months after the baseline MRI
measure: Phonophobia (number)
timeFrame: 3 months after the baseline MRI
measure: Phonophobia (number)
timeFrame: 12 months after the baseline MRI
measure: Phonophobia (number)
timeFrame: 24 months after the baseline MRI
measure: Aggravation by Movement (number)
timeFrame: 3 months after the baseline MRI
measure: Aggravation by Movement (number)
timeFrame: 12 months after the baseline MRI
measure: Aggravation by Movement (number)
timeFrame: 24 months after the baseline MRI
measure: Response to Acute Treatment
timeFrame: 3 months after the baseline MRI
measure: Response to Acute Treatment
timeFrame: 12 months after the baseline MRI
measure: Response to Acute Treatment
timeFrame: 24 months after the baseline MRI
measure: Response to Prophylactic Treatment
timeFrame: 3 months after the baseline MRI
measure: Response to Prophylactic Treatment
timeFrame: 12 months after the baseline MRI
measure: Response to Prophylactic Treatment
timeFrame: 24 months after the baseline MRI
measure: Migraine Disability Assessment Test Total Score
timeFrame: 3 months after the baseline MRI
measure: Migraine Disability Assessment Test Total Score
timeFrame: 12 months after the baseline MRI
measure: Migraine Disability Assessment Test Total Score
timeFrame: 24 months after the baseline MRI
measure: Patient Health Questionnaire 9 Depression Scale Total Score
timeFrame: 3 months after the baseline MRI
measure: Patient Health Questionnaire 9 Depression Scale Total Score
timeFrame: 12 months after the baseline MRI
measure: Patient Health Questionnaire 9 Depression Scale Total Score
timeFrame: 24 months after the baseline MRI
measure: Generalized Anxiety Disorder Assessment 7-item Scale Total Score
timeFrame: 3 months after the baseline MRI
measure: Generalized Anxiety Disorder Assessment 7-item Scale Total Score
timeFrame: 12 months after the baseline MRI
measure: Generalized Anxiety Disorder Assessment 7-item Scale Total Score
timeFrame: 24 months after the baseline MRI
measure: Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
timeFrame: 3 months after the baseline MRI
measure: Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
timeFrame: 12 months after the baseline MRI
measure: Quality and Patterns of Sleep Using Pittsburgh Sleep Quality Index Total Score
timeFrame: 24 months after the baseline MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Dai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: