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

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ClinicalTrials.gov Identifier: NCT02708797
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Migraine With Aura Other: Magnetic resonance imaging Other: Transcranial Doppler Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.
Actual Study Start Date : May 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler [ Time Frame: 30 days after pre-inclusion visit ]
  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708797


Locations
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France
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Vincent LARRUE, MD CHU Toulouse

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02708797     History of Changes
Other Study ID Numbers: RC31/15/7815
2015-A01982-47 ( Other Identifier: ID-RCB )
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Toulouse:
Cerebral autoregulation
MRI
VBM
Doppler Transcranial

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases