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Prediction of WMH in Migraine Using a BOLD-CVR Map

Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03494673
Enrollment
74
Registered
2018-04-11
Start date
2018-07-13
Completion date
2020-02-28
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

White matter hyperintensity, Cerebrovascular reactivity

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.

Interventions

DIAGNOSTIC_TESTBOLD MRI

1. Prospective End-tidal targeting RespirAct device(A specially designed gas blender and sequential rebreathing circuit) will be used to implement the gas targeting method which involves precise elevations in End-tidal PCO2 while maintaining a fixed End-tidal PO2 2. BOLD MR images will be obtained by using a T2\*-weighted two-dimensional gradient-echo sequence with echoplanar readout.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CVR association with WMH development1-year follow-up (2nd year)The investigators will obtain a CVR map using BOLD MR signal in the first year of study and also obtain changes in WMH during 2 years of follow-up period in patients and controls, respectively. Then the investigators will test whether CVR-map predicts consequent WMH development in patients and controls, respectively.

Secondary

MeasureTime frameDescription
Spatial pattern of CVRbaseline(1st year)The investigators will obtain a CVR map for each voxel using BOLD MR signal in response to % increase in EtCO2 respectively in patients and controls. Spatial pattern of CVR will be compared between patients and controls.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026