Prediction of WMH in Migraine Using a BOLD-CVR Map

NCT ID: NCT03494673

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2020-02-28

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.

Conditions

Migraine

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

Normal controls without headaches will undergo BOLD MRI with prospective CO2 targeting

BOLD MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Migraineurs

Patients diagnosed with migraine based on the ICHD-3 beta will undergo BOLD MRI with prospective CO2 targeting

BOLD MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

BOLD 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chin-Sang Chung

MD, PhD, Professor of neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Ji Lee, MD

Role: STUDY_DIRECTOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2017-04-049

Identifier Type: -

Identifier Source: org_study_id