Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura

June 24, 2018 updated by: Wei Qin, Xidian University
Recently, radiomics combined with machine learning method has been widely used in clinical practice. Compared with traditional imaging studies that explore the underlying mechanisms, the machine learning method focuses on classification and prediction to propose personalized diagnosis and treatment strategies. However, these studies were based on thin-section research-quality brain MR imaging with section thickness of < 2 mm. Clinical, the usage of thick-section clinical setting instead of thin-section research setting is especially important to shorten the acquisition time to reduce the patient's suffering. Here investigators want to build multiparametric diagnostic model of migraineurs without aura using radiomics features extracted from thick-section clinical-quality brain MR images.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

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

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 migraineurs without aura 200 age- and gender-matched health controls (HCs)

Description

Inclusion Criteria:

  • right-handed
  • International Headache Society criteria for episodic migraine without aura

Exclusion Criteria:

  • addition (including alcohol, nicotine, or drug)
  • physical illness

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
Intervention / Treatment
migraineurs without aura
Diagnostic test: diagnostic
using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.
health controls
Diagnostic test: diagnostic
using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy
Time Frame: 2018.7-2019.12
a measure of statistical bias which measures the proportion of health controls and migrainures that are correctly identified as such.
2018.7-2019.12
sensitivity
Time Frame: 2018.7-2019.12
true positive rate of detection in migraineurs which measures the proportion of actual migraineurs that are correctly identified as such.
2018.7-2019.12
specificity
Time Frame: 2018.7-2019.12
true negative rate measures the proportion of actual health controls that are correctly identified as such.
2018.7-2019.12

Collaborators and Investigators

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

Sponsor

Xidian University

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 (ANTICIPATED)

July 1, 2018

Primary Completion (ANTICIPATED)

December 30, 2018

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (ACTUAL)

June 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 24, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170908010418

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.

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