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

Migraine Without Aura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03570086
• Other study ID #: 20170908010418
• Status: Not yet recruiting
• Start date: July 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2018
• Source: Xidian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• right-handed

• International Headache Society criteria for episodic migraine without aura

Exclusion Criteria:

• addition (including alcohol, nicotine, or drug)

• physical illness

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

Diagnostic Test:
• diagnostic
using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xidian University

Country where clinical trial is conducted

China, 

Outcome

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