Migraine Without AuraNCT03570086
Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura
An observational study of Migraine Without Aura, run by Xidian University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- diagnostic
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 200 migraineurs without aura 200 age- and gender-matched health controls (HCs)
Who may be able to join
- right-handed
- International Headache Society criteria for episodic migraine without aura
Who cannot join
- addition (including alcohol, nicotine, or drug)
- physical illness
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Migraine Without Aura
- Being tested
- diagnostic
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosticDiagnostic test
using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.
| Study group | Role | What they receive |
|---|---|---|
| migraineurs without aura | Not described Receives: Diagnostic Test: diagnostic | |
| health controls | Not described Receives: Diagnostic Test: diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
a measure of statistical bias which measures the proportion of health controls and migrainures that are correctly identified as such.
Measured: 2018.7-2019.12
sensitivity
true positive rate of detection in migraineurs which measures the proportion of actual migraineurs that are correctly identified as such.
Measured: 2018.7-2019.12
specificity
true negative rate measures the proportion of actual health controls that are correctly identified as such.
Measured: 2018.7-2019.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Qin, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570086
- Sponsor's protocol ID
- 20170908010418
- Status last verified
- Jun 2018
- First submitted
- 28 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Diagnostic Model of Thick-section Clinical-quality MRI Data in Detecting Migraine Without Aura
- ClinicalTrials.gov ID
- NCT03570086
- Acronym / sponsor ID
- 20170908010418
- Conditions
- Migraine Without Aura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| migraineurs without aura | – | Diagnostic Test: diagnostic |
| health controls | – | Diagnostic Test: diagnostic |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 migraineurs without aura 200 age- and gender-matched health controls (HCs)
Key inclusion criteria (2 listed)
- right-handed
- International Headache Society criteria for episodic migraine without aura
Key exclusion criteria (2 listed)
- addition (including alcohol, nicotine, or drug)
- physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosticusing radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls. | Diagnostic test | health controls, migraineurs without aura |
Primary outcome
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.
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.
specificity
Time frame: 2018.7-2019.12
true negative rate measures the proportion of actual health controls that are correctly identified as such.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Without Aura, run by Xidian University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 2018.7-2019.12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.