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Status unknownNCT03418766CAMBRAINUpdated Jul 23, 2020

The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine

An observational study in White Matter Disease, Right-to-left Shunt and Migraine Disorders, sponsored by The First Hospital of Jilin University. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by The First Hospital of Jilin University · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese migraineurs with and without right-to-left shunt. The aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.

Read the detailed description

This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and migraine diagnosis). For all the participants, brain MRI and c-TCD are required. Up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period.

The information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and Headache Impact Test-6 (HIT-6) questionnaire.

02

Conditions studied

  • White Matter Disease
  • Right-to-left Shunt
  • Migraine Disorders

Keywords

  • Right-to-left Shunt
  • Brain White Matter Lesions
  • Migraine
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

We detect RLS through contrast-enhanced transcranial Doppler (c-TCD). The normal individuals will be selected to group 1, while those who suffer from migraine will be selected to group 2. All the participants are required to take c-TCD and brain MRI.

Inclusion criteria

  • patients who fulfilled the criteria for migraine according to the International Classification of Headache Disorders III-beta were included.

healthy volunteers without a history of migraine were included as controls.

Exclusion criteria

Exclusion Criteria:

  • Subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the Valsalva manoeuvre (VM) because of severe heart or lung disease.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Normal

    Normal healthy individual without migraine.

  • Magraine

    Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.

05

What researchers measure

Primary outcomes

  1. contrast-enhanced transcranial Doppler (c-TCD)

    Brain MRI

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • First hospital of Jilin Uni
    Changchun, Jilin 130000, China
    • Yingqi Xing, PhD · Contact
    • Yishui Zhang, MD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Del Sette M, Dinia L, Bonzano L, Roccatagliata L, Finocchi C, Parodi RC, Sivori G, Gandolfo C. White matter lesions in migraine and right-to-left shunt: a conventional and diffusion MRI study. Cephalalgia. 2008 Apr;28(4):376-82. doi: 10.1111/j.1468-2982.2008.01544.x. Epub 2008 Feb 22. PubMed 18294247 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03418766
Lead sponsor
The First Hospital of Jilin University
Collaborators
National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Jun 15, 2018
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Jul 23, 2020

Study contacts

Yingqi Xing, MD,PhD
Contact
xingyq2009@sina.com
15844047846
Sibo Wang, MD,PhD
Contact
wangsibo92@163.com
15844008297
Yingqi Xing, MD,PhD
study chair · The First Hospital of Jilin University
Sibo Wang, MD,PhD
principal investigator · The First Hospital of Jilin University
Yi Yang, MD,PhD
study director · The First Hospital of Jilin University
Yongsheng Gao, MD
principal investigator · The First Hospital of Jilin University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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