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

Migraine Disorders Clinical Trial

— CAMBRAIN  

Official title:

The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Chinese Patients With Migraine:a Multicenter Study. CAMBRAIN Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418766
• Other study ID #: CAMBRAIN
• Status: Recruiting
• Start date: June 15, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: First Hospital of Jilin University
• Contact: Yingqi Xing, MD,PhD
• Phone: 15844047846
• Email: xingyq2009[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 30, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	First hospital of Jilin Uni	Changchun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of Jilin University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (1)

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.1468-2982.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contrast-enhanced transcranial Doppler (c-TCD)	Brain MRI	1 year