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Prediction of WMH in Migraine Using a BOLD-CVR Map

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ClinicalTrials.gov Identifier: NCT03494673
Recruitment Status : Not yet recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Chin-Sang Chung, Samsung Medical Center

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.

Condition or disease Intervention/treatment
Migraine Diagnostic Test: BOLD MRI

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Group/Cohort Intervention/treatment
Control
Normal controls without headaches will undergo BOLD MRI with prospective CO2 targeting
Diagnostic Test: 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.

Migraineurs
Patients diagnosed with migraine based on the ICHD-3 beta will undergo BOLD MRI with prospective CO2 targeting
Diagnostic Test: 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.




Primary Outcome Measures :
  1. CVR association with WMH development [ Time Frame: 1-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 Outcome Measures :
  1. Spatial pattern of CVR [ Time Frame: baseline(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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Controls and migraineurs who visited to a single university hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494673


Contacts
Contact: Mi Ji Lee, MD 82-2-3410-1895 mijilee.md@gmail.com

Sponsors and Collaborators
Samsung Medical Center
National Research Foundation of Korea
Investigators
Study Director: Mi Ji Lee, MD Samsung Medical Center, Sungkyunkwan University School of Medicine

Responsible Party: Chin-Sang Chung, MD, PhD, Professor of neurology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03494673     History of Changes
Other Study ID Numbers: 2017-04-049
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chin-Sang Chung, Samsung Medical Center:
White matter hyperintensity
Cerebrovascular reactivity

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases