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

• Conditions: Right-to-left Shunt; Migraine Disorders; White Matter Disease

• Registration Number: NCT03418766
• Lead Sponsor: The First Hospital of Jilin University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-02-01
• Study Start: 2018-06-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
contrast-enhanced transcranial Doppler (c-TCD)	1 year	Brain MRI

Trial Locations

Locations (1)

First hospital of Jilin Uni; 🇨🇳 Changchun, Jilin, China