Clinical trial NCT01803984: MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
Official title: MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Migraine
Keywords: Migraine
Brain structure
MRI
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* pregnant woman
* patient with a serious psychiatric psychological illness
* patient having a serious anxiety (claustrophobia)
* Patient bearing an electronic or a metallic device (pacemaker)

Primary outcomes:
measure: Differences in magnetic resonance imaging (MRI) between migraine without aura and migraine with aura patients (frequency of hyperintensities, white matter lesions....)
timeFrame: Within 3 months after inclusion
measure: 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.
timeFrame: Baseline
measure: Differences in the Reactive Hyperemia Index (RHI) and the Augmentation Index (AI) between migraine without aura and migraine with aura patients
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between MRI and Total Score of RBANS with RHI / AI (endothelial function) between migraine groups.
timeFrame: Within 3 months after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
affiliation: Inserm Unit 708 - Neuroépidemiologie
name: Tobias KURTH, MD
role: PRINCIPAL_INVESTIGATOR
References: