NCT03494673

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

March 28, 2018

Last Update Submit

April 9, 2019

Conditions

Migraine

Keywords

White matter hyperintensityCerebrovascular reactivity

Outcome Measures

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.

    1-year follow-up (2nd year)

Secondary Outcomes (1)

  • Spatial pattern of CVR

    baseline(1st year)

Study Arms (2)

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

BOLD MRIDIAGNOSTIC_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.

ControlMigraineurs

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Controls and migraineurs who visited to a single university hospital

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mi Ji Lee, MD

    Samsung Medical Center, Sungkyunkwan University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of neurology

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 11, 2018

Study Start

July 13, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

KR(1)