Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura. (MINOTAURE)

July 28, 2020 updated by: University Hospital, Toulouse

Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.

Migraine with aura (MA) is an independent risk factor for stroke and is associated with silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA patients. Studies with positron emission tomography have demonstrated an activation of brain stem areas during migraine attack. An increased density of brain stem grey matter as measured on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study hypothesize a negative correlation between the density of brainstem nuclei and the efficiency of cerebral autoregulation in MA patients compared with controls.

Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the time domain using Transcranial Doppler (TCD) and the Mx method.

MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are non-invasive technics and will be performed on the same day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Migraine with aura patients : fulfilling the International Classification of Headache Disorders-3 beta criteria of MA
  • Control group : Gender- and age-matched subjects without history of migraine with or without aura or any other headache

Exclusion Criteria:

  • History of illness or injury of central or peripherical nervous system
  • Previous history of a disease potentially impairing cerebral autoregulation (diabetes, sleep apnea syndrome, uncontrolled hypertension, cardiac arrhythmia, hearth failure, carotid stenosis)
  • Contraindications related to MRI
  • Absence of temporal acoustic window
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Migraine with aura Patients
Patients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Other: Magnetic resonance imaging
Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
Other: Transcranial Doppler
Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
Other: Controls
Control group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Other: Magnetic resonance imaging
Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
Other: Transcranial Doppler
Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the density of the pontine grey matter evaluated with resonance magnetic imaging, and cerebral autoregulation measured with Transcranial Doppler in migraine with aura patients and controls.
Time Frame: 30 days after the pre-inclusion visit
Resonance magnetic imaging use voxel base morphometry and Transcranial doppler use the coefficient mx calculation.
30 days after the pre-inclusion visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of brainstem grey matter density between migraine with aura patients and controls with magnetic resonance imaging
Time Frame: 30 days after pre-inclusion visit
Comparison will be done with software using voxel based morphometry (VBM) function in addition of imaging with resonance magnetic imaging.
30 days after pre-inclusion visit
Comparison of cerebral autoregulation between migraine with aura patients and controls with Transcranial Doppler
Time Frame: 30 days after pre-inclusion visit
Comparison will be done using the calculation of mx coefficient in addition of imaging with Transcranial Doppler.
30 days after pre-inclusion visit
Comparison of cerebrovascular reactivity to carbon dioxide between migraine with aura patients and controls with Transcranial Doppler
Time Frame: 30 days after pre-inclusion visit
Comparison will be done using voluntary apnea test in addition of imaging with Transcranial Doppler.
30 days after pre-inclusion visit
Comparison of morphological abnormalities between migraine with aura patients and controls with resonance magnetic imaging.
Time Frame: 30 days after pre-inclusion visit
Comparison will be done using T2 white matter hyperintensities and silent brain infracts on resonance magnetic imaging.
30 days after pre-inclusion visit
Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
Time Frame: 30 days after pre-inclusion visit
30 days after pre-inclusion visit
Association between grey matter density and morphological abnormalities on resonance magnetic imaging
Time Frame: 30 days after pre-inclusion visit
Association will be determined using T2 white matter hyperintensities, silent brain infracts and voxel based morphometry function of software
30 days after pre-inclusion visit
Association between cerebral autoregulation and morphological abnormalities on magnetic resonance imaging
Time Frame: 30 days after pre-inclusion visit
Association will be determined using T2 white matter hyperintensities, silent brain infracts and calculation of mx coefficient
30 days after pre-inclusion visit
Relation between baroreflex sensitivity and cerebral autoregulation with Transcranial Doppler.
Time Frame: 30 days after pre-inclusion visit
Relation will be determined using the calculation of mx coefficient in addition of imaging with Transcranial Doppler
30 days after pre-inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Vincent LARRUE, MD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/15/7815
  • 2015-A01982-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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