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
  Purpose

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.


Condition Intervention
Migraine
Device: MRI
Device: EndoPAT
Other: Neuropsychological battery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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 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
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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803984

Contacts
Contact: Tobias Kurth, MD +33 5 47 30 42 56 tobias.kurth@univ-bordeaux.fr

Locations
France
Centre Hospitalier Universitaire de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Tobias KURTH, MD    +33 5 47 30 42 56    tobias.kurth@univ-bordeaux.fr   
Principal Investigator: Virginie DOUSSET, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Tobias KURTH, MD Inserm Unit 708 - Neuroépidemiologie
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01803984     History of Changes
Other Study ID Numbers: CHUBX 2012/19
Study First Received: February 27, 2013
Last Updated: March 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
Migraine
Brain structure
MRI

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014