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

Primary Purpose

Migraine With Aura

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging
Transcranial Doppler
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine With Aura focused on measuring Cerebral autoregulation, MRI, VBM, Doppler Transcranial

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Migraine with aura Patients

Controls

Arm Description

Patients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.

Control group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.

Outcomes

Primary Outcome Measures

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.
Resonance magnetic imaging use voxel base morphometry and Transcranial doppler use the coefficient mx calculation.

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2016
Last Updated
July 28, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02708797
Brief Title
Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.
Acronym
MINOTAURE
Official Title
Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura
Keywords
Cerebral autoregulation, MRI, VBM, Doppler Transcranial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Migraine with aura Patients
Arm Type
Other
Arm Description
Patients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Arm Title
Controls
Arm Type
Other
Arm Description
Control group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Intervention Type
Other
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
Intervention Type
Other
Intervention Name(s)
Transcranial Doppler
Intervention Description
Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
Primary Outcome Measure Information:
Title
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.
Description
Resonance magnetic imaging use voxel base morphometry and Transcranial doppler use the coefficient mx calculation.
Time Frame
30 days after the pre-inclusion visit
Secondary Outcome Measure Information:
Title
Comparison of brainstem grey matter density between migraine with aura patients and controls with magnetic resonance imaging
Description
Comparison will be done with software using voxel based morphometry (VBM) function in addition of imaging with resonance magnetic imaging.
Time Frame
30 days after pre-inclusion visit
Title
Comparison of cerebral autoregulation between migraine with aura patients and controls with Transcranial Doppler
Description
Comparison will be done using the calculation of mx coefficient in addition of imaging with Transcranial Doppler.
Time Frame
30 days after pre-inclusion visit
Title
Comparison of cerebrovascular reactivity to carbon dioxide between migraine with aura patients and controls with Transcranial Doppler
Description
Comparison will be done using voluntary apnea test in addition of imaging with Transcranial Doppler.
Time Frame
30 days after pre-inclusion visit
Title
Comparison of morphological abnormalities between migraine with aura patients and controls with resonance magnetic imaging.
Description
Comparison will be done using T2 white matter hyperintensities and silent brain infracts on resonance magnetic imaging.
Time Frame
30 days after pre-inclusion visit
Title
Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
Time Frame
30 days after pre-inclusion visit
Title
Association between grey matter density and morphological abnormalities on resonance magnetic imaging
Description
Association will be determined using T2 white matter hyperintensities, silent brain infracts and voxel based morphometry function of software
Time Frame
30 days after pre-inclusion visit
Title
Association between cerebral autoregulation and morphological abnormalities on magnetic resonance imaging
Description
Association will be determined using T2 white matter hyperintensities, silent brain infracts and calculation of mx coefficient
Time Frame
30 days after pre-inclusion visit
Title
Relation between baroreflex sensitivity and cerebral autoregulation with Transcranial Doppler.
Description
Relation will be determined using the calculation of mx coefficient in addition of imaging with Transcranial Doppler
Time Frame
30 days after pre-inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent LARRUE, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30296840
Citation
Gollion C, Nasr N, Fabre N, Barege M, Kermorgant M, Marquine L, Larrue V. Cerebral autoregulation in migraine with aura: A case control study. Cephalalgia. 2019 Apr;39(5):635-640. doi: 10.1177/0333102418806861. Epub 2018 Oct 8.
Results Reference
result
PubMed Identifier
35982396
Citation
Gollion C, Lerebours F, Nemmi F, Arribarat G, Bonneville F, Larrue V, Peran P. Insular functional connectivity in migraine with aura. J Headache Pain. 2022 Aug 19;23(1):106. doi: 10.1186/s10194-022-01473-1.
Results Reference
derived

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Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.

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