Prediction of WMH in Migraine Using a BOLD-CVR Map

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03494673
• Other study ID #: 2017-04-049
• Status: Active, not recruiting
• Start date: July 13, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Diagnostic Test:
• BOLD MRI
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 BOLD MR images will be obtained by using a T2*-weighted two-dimensional gradient-echo sequence with echoplanar readout.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CVR association with WMH development	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.	1-year follow-up (2nd year)
Secondary	Spatial pattern of CVR	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.	baseline(1st year)