MigraineNCT03494673
Prediction of WMH in Migraine Using a BOLD-CVR Map
An observational study of Migraine, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs. 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?
- BOLD MRI
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2018to 28 Feb 2020
- 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
- Migraineurs(patients) :
- 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)
- migraine duration > 6 months
- episodic migraine feature headache (< 15 attacks/m)
- not any preventive medications for migraine
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- Control:
- age 18-50 years
- no headache disorder requiring painkillers within the past year
- no more than moderate intensity of headache within the past year
- no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta
Who cannot join
- chronic migraine within last month (≥15 attacks/m)
- medication overuse headache as defined by ICHD-3 beta
- other comorbid disease that may affect vascular function (Hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc)
- can not breath 20 L for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc)
- a disease that can be exacerbated by elevated PCO2 in blood (Interstitial lung disease, amyotrophic lateral sclerosis etc)
- predicted to be unable to write the headache diary due to cognitive decline
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- contraindications to MRI
- pregnancy
- refusal to informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI
Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs.
Read the detailed description
A whole-brain map of CVR will be created in patients with migraine and normal controls. Hypercapnic stimuli for CVR will be delivered by prospective end-tidal CO2 targeting device. Hemodynamic responses will be determined by BOLD signal changes using fMRI. WMHs will be determined by high-resolution 3D FLAIR imaging. Patients and controls will undergo serial MRIs with 1 year interval. Associations between areas of reduced CVR and consequent WMH development will be tested in both patients and controls.
- Conditions
- Migraine
- Being tested
- BOLD MRI
- Keywords
- White matter hyperintensity, Cerebrovascular reactivity
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD MRIDiagnostic test
- Prospective End-tidal targeting RespirAct device(A specially designed gas blender and sequential rebreathing circuit) will be used to implement the gas targeting method which involves precise elevations in End-tidal PCO2 while maintaining a fixed End-tidal PO2
- BOLD MR images will be obtained by using a T2*-weighted two-dimensional gradient-echo sequence with echoplanar readout.
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal controls without headaches will undergo BOLD MRI with prospective CO2 targeting Receives: Diagnostic Test: BOLD MRI | |
| Migraineurs | Patients diagnosed with migraine based on the ICHD-3 beta will undergo BOLD MRI with prospective CO2 targeting Receives: Diagnostic Test: BOLD MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVR association with WMH development
The investigators will obtain a CVR map using BOLD MR signal in the first year of study and also obtain changes in WMH during 2 years of follow-up period in patients and controls, respectively. Then the investigators will test whether CVR-map predicts consequent WMH development in patients and controls, respectively.
Measured: 1-year follow-up (2nd year)
Secondary outcomes (1)
Spatial pattern of CVR
The investigators will obtain a CVR map for each voxel using BOLD MR signal in response to % increase in EtCO2 respectively in patients and controls. Spatial pattern of CVR will be compared between patients and controls.
Measured: baseline(1st year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start13 Jul 2018
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Chin-Sang Chung, Samsung Medical Center
- Investigators
- Mi Ji Lee, MD, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494673
- Sponsor's protocol ID
- 2017-04-049
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2018
- Last updated
- 10 Apr 2019
- 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 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Brain White Matter Hyperintensity in Migraine Using a Cerebrovascular Reactivity Mapping Based on BOLD MRI
- ClinicalTrials.gov ID
- NCT03494673
- Acronym / sponsor ID
- 2017-04-049
- Conditions
- Migraine
- Keywords
- White matter hyperintensity, Cerebrovascular reactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 11 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.
Brain white matter hyperintensities (WMHs) are prevalent in migraineurs, of which the mechanism is still unclear. The investigators aimed to test the spatial association between areas with reduced cerebrovascular reactivity (CVR) to hypercapnic stimuli and consequent development of WMHs.
Detailed description
A whole-brain map of CVR will be created in patients with migraine and normal controls. Hypercapnic stimuli for CVR will be delivered by prospective end-tidal CO2 targeting device. Hemodynamic responses will be determined by BOLD signal changes using fMRI. WMHs will be determined by high-resolution 3D FLAIR imaging. Patients and controls will undergo serial MRIs with 1 year interval. Associations between areas of reduced CVR and consequent WMH development will be tested in both patients and controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: BOLD MRINormal controls without headaches will undergo BOLD MRI with prospective CO2 targeting |
| Migraineurs | – | Diagnostic Test: BOLD MRIPatients diagnosed with migraine based on the ICHD-3 beta will undergo BOLD MRI with prospective CO2 targeting |
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 (11 listed)
- Migraineurs(patients) :
- Control:
Key exclusion criteria (9 listed)
- chronic migraine within last month (≥15 attacks/m)
- medication overuse headache as defined by ICHD-3 beta
- other comorbid disease that may affect vascular function (Hypertension, diabetes, hyperlipidemia, cerebral infarction, smoking etc)
- can not breath 20 L for 1 minute because of basal cardiopulmonary disease (chronic obstructive pulmonary disease, heart failure etc)
- a disease that can be exacerbated by elevated PCO2 in blood (Interstitial lung disease, amyotrophic lateral sclerosis etc)
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 |
|---|---|---|
| BOLD MRI1. Prospective End-tidal targeting RespirAct device(A specially designed gas blender and sequential rebreathing circuit) will be used to implement the gas targeting method which involves precise elevations in End-tidal PCO2 while maintaining a fixed End-tidal PO2 2. BOLD MR images will be obtained by using a T2*-weighted two-dimensional gradient-echo sequence with echoplanar readout. | Diagnostic test | Control, Migraineurs |
Primary outcome
CVR association with WMH development
Time frame: 1-year follow-up (2nd year)
The investigators will obtain a CVR map using BOLD MR signal in the first year of study and also obtain changes in WMH during 2 years of follow-up period in patients and controls, respectively. Then the investigators will test whether CVR-map predicts consequent WMH development in patients and controls, respectively.
1 secondary outcome
Spatial pattern of CVR
Time frame: baseline(1st year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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 study director
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 11 inclusion and 9 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 10 Apr 2019. 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?
CVR association with WMH development (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?
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 10 Apr 2019.