MigraineNCT03487978
Longitudinal Changes of Brain Functional Connectivity in Migraine
An observational study of Migraine, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- resting-state functional MRI
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2017to 28 Feb 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Controls and migraineurs who visited to a single university hospital
Who may be able to join
- Migrainuers :
- age 18-50 years
- migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
- if female, before the onset of menopausal
- Controls:
- age 18-50 years
- no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta
Who cannot join
- contraindicated to MRI
- pregnancy
- require sedation treatment because of claustrophobia when performing MRI
- predicted to be unable to write the headache diary due to cognitive decline
- refuse study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.
Read the detailed description
Migraine is associated with functional alterations in specific brain networks. The investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. The investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. The investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.
- Conditions
- Migraine
- Being tested
- resting-state functional MRI
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resting-state functional MRIDiagnostic test
- To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure.
- Record the time difference between the date on the day of fMRI and the date of the last headache attack and record whether the headache on the day of fMRI is absent or not.
- On the third day after MRI, examine whether the subject has headache or not.
| Study group | Role | What they receive |
|---|---|---|
| Migraineurs | Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI. Receives: Diagnostic Test: resting-state functional MRI | |
| Control | Normal controls without headaches will undergo 3-tesla resting-state functional MRI. Receives: Diagnostic Test: resting-state functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core fMRI features for migraine brain
Among significant networks identified by ICA, we will identify altered networks which remain unchanged in follow-up resting-state fMRI in 1 year.
Measured: 1-year follow-up (2nd year)
Secondary outcomes (2)
Candidate fMRI features for migraine
Using baseline resting-state fMRI, altered brain networks associated with migraine will be identified by independent component analysis (ICA) between patients and controls.
Measured: Baseline (1st year)
Dynamic fMRI features for disease severity
Among significant networks identified by ICA, we will identify altered networks which change in association with changes in headache frequency in follow-up resting-state fMRI in 1 year.
Measured: 1-year follow-up (2nd year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start24 Jul 2017
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea, Sungkyunkwan University
- Responsible party
- Principal investigator, Chin-Sang Chung, Samsung Medical Center
- Investigators
- Mi Ji Lee, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487978
- Sponsor's protocol ID
- 2017-03-113
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park Y, Lee MJ, Yoo S, Kim CY, Namgung JY, Park Y, Park H, Lee EC, Yoon YD, Paquola C, Bernhardt BC, Park BY. GAN-MAT: Generative adversarial network-based microstructural profile covariance analysis toolbox. Neuroimage. 2024 May 1;291:120595. doi: 10.1016/j.neuroimage.2024.120595. Epub 2024 Mar 29.
PubMed 38554782
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
- ClinicalTrials.gov ID
- NCT03487978
- Acronym / sponsor ID
- 2017-03-113
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea, Sungkyunkwan University
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 4 Apr 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.
The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.
Detailed description
Migraine is associated with functional alterations in specific brain networks. The investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. The investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. The investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraineurs | – | Diagnostic Test: resting-state functional MRIPatients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI. |
| Control | – | Diagnostic Test: resting-state functional MRINormal controls without headaches will undergo 3-tesla resting-state functional MRI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Controls and migraineurs who visited to a single university hospital
Key inclusion criteria (7 listed)
- age 18-50 years
- migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
- if female, before the onset of menopausal
- age 18-50 years
- no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta
Key exclusion criteria (5 listed)
- contraindicated to MRI
- pregnancy
- require sedation treatment because of claustrophobia when performing MRI
- predicted to be unable to write the headache diary due to cognitive decline
- refuse study procedure
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 |
|---|---|---|
| resting-state functional MRI1. To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure. 2. Record the time difference between the date on the day of fMRI and the date of the last headache attack and record whether the headache on the day of fMRI is absent or not. 3. On the third day after MRI, examine whether the subject has headache or not. | Diagnostic test | Control, Migraineurs |
Primary outcome
Core fMRI features for migraine brain
Time frame: 1-year follow-up (2nd year)
Among significant networks identified by ICA, we will identify altered networks which remain unchanged in follow-up resting-state fMRI in 1 year.
2 secondary outcomes
Candidate fMRI features for migraine
Time frame: Baseline (1st year)
Dynamic fMRI features for disease severity
Time frame: 1-year follow-up (2nd year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 38554782Park Y, Lee MJ, Yoo S, Kim CY, Namgung JY, Park Y, Park H, Lee EC, Yoon YD, Paquola C, Bernhardt BC, Park BY. GAN-MAT: Generative adversarial network-based microstructural profile covariance analysis toolbox. Neuroimage. 2024 May 1;291:120595. doi: 10.1016/j.neuroimage.2024.120595. Epub 2024 Mar 29.
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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.
Mi Ji Lee, MD principal investigator
Samsung Medical Center
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, run by Samsung Medical Center at 1 site in South Korea.
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 7 inclusion and 5 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 20 Mar 2020. 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 South Korea. 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?
Core fMRI features for migraine brain (time frame: 1-year follow-up (2nd year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487978, which also lists 1 linked publication.
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 20 Mar 2020.