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

NCT01803984 | Terminated

• 1 other identifier: CHUBX 2012/19
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Brain structure; MRI

Outcome Measures

Primary Outcomes (3)

• Differences in magnetic resonance imaging (MRI) between migraine without aura and migraine with aura patients (frequency of hyperintensities, white matter lesions....)

  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.

  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.

  Baseline

Secondary Outcomes (1)

• Correlation between MRI and Total Score of RBANS with RHI / AI (endothelial function) between migraine groups.

  Within 3 months after inclusion

Study Arms (2)

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; 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

Device: MRI; Device: EndoPAT; Other: Neuropsychological battery

Interventions

MRI DEVICE

Patient with migraine with aura; Patient with migraine without aura

EndoPAT DEVICE

The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device

Patient with migraine with aura; Patient with migraine without aura

Neuropsychological battery OTHER

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; Patient with migraine without aura

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tobias KURTH, MD

  Inserm Unit 708 - Neuroépidemiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 4, 2013
• Study Start: March 22, 2013
• Primary Completion: December 3, 2014
• Study Completion: December 3, 2014
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

FR (1)