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Prediction of WMH in Migraine Using a BOLD-CVR Map

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Samsung Medical Center

Status

Unknown

Conditions

Migraine

Treatments

Diagnostic Test: BOLD MRI

Study type

Observational

Funder types

Other

Identifiers

NCT03494673
2017-04-049

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

74 participants in 2 patient groups

Control
Description:
Normal controls without headaches will undergo BOLD MRI with prospective CO2 targeting
Treatment:
Diagnostic Test: BOLD MRI
Migraineurs
Description:
Patients diagnosed with migraine based on the ICHD-3 beta will undergo BOLD MRI with prospective CO2 targeting
Treatment:
Diagnostic Test: BOLD MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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