MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01803984
First received: February 27, 2013
Last updated: March 11, 2014
Last verified: March 2014

February 27, 2013
March 11, 2014
March 2013
June 2015   (final data collection date for 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    RHI will measured by the non invasive endothelial peripheral arterial tomography (EndoPat 2000 Itamar Medical Ltd) device.
Same as current
Complete list of historical versions of study NCT01803984 on ClinicalTrials.gov Archive Site
Correlation between MRI and Total Score of RBANS with RHI / AI (endothelial function) between migraine groups. [ Time Frame: Within 3 months after inclusion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction
MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Not Provided
Non-Probability Sample

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.

Migraine
  • Device: MRI
  • Device: EndoPAT
    The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device
  • Other: Neuropsychological battery
    The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
  • 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.
    Interventions:
    • 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
    Interventions:
    • Device: MRI
    • Device: EndoPAT
    • Other: Neuropsychological battery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2015
June 2015   (final data collection date for primary outcome measure)

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)
Both
30 Years and older
No
Contact: Tobias Kurth, MD +33 5 47 30 42 56 tobias.kurth@univ-bordeaux.fr
France
 
NCT01803984
CHUBX 2012/19
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Tobias KURTH, MD Inserm Unit 708 - Neuroépidemiologie
University Hospital, Bordeaux
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP