MigraineMIBRAINNCT01803984
MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
An observational study of Migraine, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- MRI, EndoPAT and Neuropsychological battery
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2013to 3 Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a clearly defined migraine (as per IHS criteria) who are aged 30 and older, are able to fluently speak French, do not have a major psychiatric disease or major anxiety disorder which would not allow to perform a MRI imaging, and who are willing to participate.
Who may be able to join
- Patient with migraine according to the criteria defined by the International Headache Society (ICHD-II)
- Patient aged 30 years old and older
- Patient speaking fluent french
Who cannot join
- pregnant woman
- patient with a serious psychiatric psychological illness
- patient having a serious anxiety (claustrophobia)
- Patient bearing an electronic or a metallic device (pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated with structural brain changes independent of the occurrence of stroke.
As migraine has strong links with the vascular system, it is plausible that vascular functions interact on the association between migraine and structural brain changes as well as cognition.
Read more
Our primary objectives are to investigate: (i) the relationship of migraine and migraine subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active migraine; (ii) the relationship of migraine on cognitive performance among patients with active migraine; and (iii) the relationship of migraine and migraine specifics with vascular functions and morbidity. As secondary objective, we investigate whether the association of migraine on structural brain changes or cognitive performance is modified by vascular functions.
This will be an observational study conducted in the Headache Center in Bordeaux. 300 patients have to be included (150 patients with migraine with aura and 150 patients with migraine without aura).
Inclusion criteria are: all patients with a clearly defined migraine (as per IHS[International Headache Classification] criteria) who are aged 30 and older, are able to fluently speak French, and who are willing to participate.
Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).
The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the depression scale CES-D (Center for Epidemiologic Studies Depression Scale).
Vascular risk status will be assessed by measurement of blood pressure and reports of vascular risk factors. The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical Inc, Framingham, MA).
For crude comparisons, chi-square tests will be used for categorical variables and t-test for continuous variables. Multivariable-multinominal modeling techniques will be utilized for the comparisons adjusting for potential confounding variables. All statistical tests will be two-tailed and a P <0.05 will be considered statistically significant.
- Conditions
- Migraine
- Being tested
- MRI, EndoPAT, Neuropsychological battery
- Keywords
- Migraine, Brain structure, 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.
MRIDevice
EndoPATDevice
The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device
Neuropsychological batteryOther
The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
| Study group | Role | What they receive |
|---|---|---|
| Patient with migraine with aura | Patients with a clearly defined migraine (as per IHS criteria) with aura, who are aged 30 and older and are able to fluently speak French. Receives: Device: MRI; Device: EndoPAT; Other: Neuropsychological battery | |
| Patient with migraine without aura | patients with a clearly defined migraine (as per IHS criteria) without aura who are aged 30 and older, are able to fluently speak French, and who are willing to participate Receives: Device: MRI; Device: EndoPAT; Other: Neuropsychological battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in magnetic resonance imaging (MRI) between migraine without aura and migraine with aura patients (frequency of hyperintensities, white matter lesions....)
Measured: Within 3 months after inclusion
Differences in the Total Score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between migraine without aura and migraine with aura patients.
The Total Score of the RBANS reflects the neurocognitive status of the patient by summing five index/domain scores. The domains are Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
Measured: Baseline
Differences in the Reactive Hyperemia Index (RHI) and the Augmentation Index (AI) between migraine without aura and migraine with aura patients
RHI will measured by the non invasive endothelial peripheral arterial tomography (EndoPat 2000 Itamar Medical Ltd) device.
Measured: Baseline
Secondary outcomes (1)
Correlation between MRI and Total Score of RBANS with RHI / AI (endothelial function) between migraine groups.
Measured: Within 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start22 Mar 2013
- Primary completion3 Dec 2014
- Study completion3 Dec 2014
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 University Hospital, BordeauxThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias KURTH, MD, Principal investigator, Inserm Unit 708 - Neuroépidemiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803984
- Sponsor's protocol ID
- CHUBX 2012/19
- Acronym
- MIBRAIN
- Status last verified
- Jun 2020
- First submitted
- 27 Feb 2013
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
- ClinicalTrials.gov ID
- NCT01803984
- Acronym / sponsor ID
- MIBRAIN / CHUBX 2012/19
- Conditions
- Migraine
- Keywords
- Migraine, Brain structure, MRI
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 22 Mar 2013 (actual)
- Primary completion
- 3 Dec 2014 (actual)
- Study completion
- 3 Dec 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- 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.
Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated with structural brain changes independent of the occurrence of stroke.
As migraine has strong links with the vascular system, it is plausible that vascular functions interact on the association between migraine and structural brain changes as well as cognition.
Our primary objectives are to investigate: (i) the relationship of migraine and migraine subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active migraine; (ii) the relationship of migraine on cognitive performance among patients with active migraine; and (iii) the relationship of migraine and migraine specifics with vascular functions and morbidity. As secondary objective, we investigate whether the association of migraine on structural brain changes or cognitive performance is modified by vascular functions.
This will be an observational study conducted in the Headache Center in Bordeaux. 300 patients have to be included (150 patients with migraine with aura and 150 patients with migraine without aura).
Inclusion criteria are: all patients with a clearly defined migraine (as per IHS[International Headache Classification] criteria) who are aged 30 and older, are able to fluently speak French, and who are willing to participate.
Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).
The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the depression scale CES-D (Center for Epidemiologic Studies Depression Scale).
Vascular risk status will be assessed by measurement of blood pressure and reports of vascular risk factors. The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical Inc, Framingham, MA).
For crude comparisons, chi-square tests will be used for categorical variables and t-test for continuous variables. Multivariable-multinominal modeling techniques will be utilized for the comparisons adjusting for potential confounding variables. All statistical tests will be two-tailed and a P <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with migraine with aura | – | Device: MRI, Device: EndoPAT, Other: Neuropsychological batteryPatients with a clearly defined migraine (as per IHS criteria) with aura, who are aged 30 and older and are able to fluently speak French. |
| Patient with migraine without aura | – | Device: MRI, Device: EndoPAT, Other: Neuropsychological batterypatients with a clearly defined migraine (as per IHS criteria) without aura who are aged 30 and older, are able to fluently speak French, and who are willing to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a clearly defined migraine (as per IHS criteria) who are aged 30 and older, are able to fluently speak French, do not have a major psychiatric disease or major anxiety disorder which would not allow to perform a MRI imaging, and who are willing to participate.
Key inclusion criteria (3 listed)
- Patient with migraine according to the criteria defined by the International Headache Society (ICHD-II)
- Patient aged 30 years old and older
- Patient speaking fluent french
Key exclusion criteria (4 listed)
- pregnant woman
- patient with a serious psychiatric psychological illness
- patient having a serious anxiety (claustrophobia)
- Patient bearing an electronic or a metallic device (pacemaker)
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 |
|---|---|---|
| MRI | Device | Patient with migraine with aura, Patient with migraine without aura |
| EndoPATThe endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device | Device | Patient with migraine with aura, Patient with migraine without aura |
| Neuropsychological batteryThe cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | Other | Patient with migraine with aura, Patient with migraine without aura |
Primary outcome
Differences in magnetic resonance imaging (MRI) between migraine without aura and migraine with aura patients (frequency of hyperintensities, white matter lesions....)
Time frame: Within 3 months after inclusion
Differences in the Total Score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between migraine without aura and migraine with aura patients.
Time frame: Baseline
The Total Score of the RBANS reflects the neurocognitive status of the patient by summing five index/domain scores. The domains are Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
Differences in the Reactive Hyperemia Index (RHI) and the Augmentation Index (AI) between migraine without aura and migraine with aura patients
Time frame: Baseline
RHI will measured by the non invasive endothelial peripheral arterial tomography (EndoPat 2000 Itamar Medical Ltd) device.
1 secondary outcome
Correlation between MRI and Total Score of RBANS with RHI / AI (endothelial function) between migraine groups.
Time frame: Within 3 months after inclusion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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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.
Tobias KURTH, MD principal investigator
Inserm Unit 708 - Neuroépidemiologie
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 University Hospital, Bordeaux at 1 site in France.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Jun 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 France. 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?
The study was stopped early. 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?
Differences in magnetic resonance imaging (MRI) between migraine without aura and migraine with aura patients (frequency of hyperintensities, white matter lesions....) (time frame: Within 3 months after inclusion). 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 18 Jun 2020.