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Completed

NCT Number: NCT02708797

Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.

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.

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Key information

Conditions

Migraine With Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Other

Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.

Transcranial doppler

Other

Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: MINOTAURE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2016
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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