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

J

Jilin University

Status

Unknown

Conditions

Migraine Disorders
White Matter Disease
Right-to-left Shunt

Study type

Observational

Funder types

Other

Identifiers

NCT03418766
CAMBRAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Normal
Description:
Normal healthy individual without migraine.
Magraine
Description:
Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.

Trial contacts and locations

1

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Central trial contact

Yingqi Xing, MD,PhD; Sibo Wang, MD,PhD

Data sourced from clinicaltrials.gov

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