Clinical trial NCT03494673: Prediction of WMH in Migraine Using a BOLD-CVR Map
Official title: Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Keywords: White matter hyperintensity
Cerebrovascular reactivity
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2018-04-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls and migraineurs who visited to a single university hospital

Brief summary: Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs.

Detailed description: A whole-brain map of CVR will be created in patients with migraine and normal controls. Hypercapnic stimuli for CVR will be delivered by prospective end-tidal CO2 targeting device. Hemodynamic responses will be determined by BOLD signal changes using fMRI. WMHs will be determined by high-resolution 3D FLAIR imaging. Patients and controls will undergo serial MRIs with 1 year interval. Associations between areas of reduced CVR and consequent WMH development will be tested in both patients and controls.

Eligibility criteria: Inclusion Criteria:

1. Migraineurs(patients) :

   * age 18-50 years
   * migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
   * migraine duration \> 6 months
   * episodic migraine feature headache (\< 15 attacks/m)
   * not any preventive medications for migraine
2. Control:

   * age 18-50 years
   * no headache disorder requiring painkillers within the past year
   * no more than moderate intensity of headache within the past year
   * no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta

Exclusion criteria:

* chronic migraine within last month (≥15 attacks/m)
* medication overuse headache as defined by ICHD-3 beta
* other comorbid disease that may affect vascular function (Hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc)
* can not breath 20 L for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc)
* a disease that can be exacerbated by elevated PCO2 in blood (Interstitial lung disease, amyotrophic lateral sclerosis etc)
* predicted to be unable to write the headache diary due to cognitive decline
* contraindications to MRI
* pregnancy
* refusal to informed consent

Primary outcomes:
measure: CVR association with WMH development
timeFrame: 1-year follow-up (2nd year)
Secondary outcomes:
measure: Spatial pattern of CVR
timeFrame: baseline(1st year)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Mi Ji Lee, MD
role: STUDY_DIRECTOR
References: