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

July 21, 2020 updated by: The First Hospital of Jilin University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • First hospital of Jilin Uni
        • Contact:
          • Yingqi Xing, PhD
        • Principal Investigator:
          • Yishui Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
contrast-enhanced transcranial Doppler (c-TCD)
Time Frame: 1 year
Brain MRI
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Collaborators

National Natural Science Foundation of China

Investigators

  • Study Chair: Yingqi Xing, MD,PhD, The first hospital of Jilin University
  • Principal Investigator: Sibo Wang, MD,PhD, The first hospital of Jilin University
  • Study Director: Yi Yang, MD,PhD, The first hospital of Jilin University
  • Principal Investigator: Yongsheng Gao, MD, The first hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMBRAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Disorders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe