We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803984
First Posted: March 4, 2013
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
February 27, 2013
March 4, 2013
January 14, 2015
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 ]
  • 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.
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 ]
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
Not Provided
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.
 
Unknown status
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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01803984
CHUBX 2012/19
No
Not Provided
Not Provided
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Tobias KURTH, MD Inserm Unit 708 - Neuroépidemiologie
University Hospital, Bordeaux
January 2015