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Status unknownNCT03494673Updated Apr 10, 2019

Prediction of WMH in Migraine Using a BOLD-CVR Map

An observational study in Migraine, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
74
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine

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Keywords

  • White matter hyperintensity
  • Cerebrovascular reactivity
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Controls and migraineurs who visited to a single university hospital

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
74 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

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

    Diagnostic Test: BOLD MRI

  • Migraineurs

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

    Diagnostic Test: BOLD MRI

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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-year follow-up (2nd year)

Secondary outcomes

  1. 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.

    Time frame: baseline(1st year)

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03494673
Lead sponsor
Samsung Medical Center
Collaborators
National Research Foundation of Korea
Responsible party
Chin-Sang Chung (MD, PhD, Professor of neurology, Samsung Medical Center) — Principal investigator
First posted
Apr 11, 2018
Start date
Jul 13, 2018
Primary completion
Feb 28, 2020 (estimated)
Completion
Feb 28, 2020 (estimated)
Last update
Apr 10, 2019

Study contacts

Mi Ji Lee, MD
study director · Samsung Medical Center, Sungkyunkwan University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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