NCT01803984: MIBRAIN

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

Terminated Last updated 18 June 2020

What this trial tests

trial testing MRI in Migraine in 166 participants. Terminated before completion.

Timeline

22 March 2013

Primary endpoint
3 December 2014

3 December 2014

Quick facts

Lead sponsor	University Hospital, Bordeaux
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	166
Start date	22 March 2013
Primary completion	3 December 2014
Estimated completion	3 December 2014
Sites	1 location across France

Drugs / interventions tested

• MRI — full drug profile →
• EndoPAT
• Neuropsychological battery

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.