Clinical trial NCT02708797: Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.
Official title: Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine With Aura
Keywords: Cerebral autoregulation
MRI
VBM
Doppler Transcranial
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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.
timeFrame: 30 days after the pre-inclusion visit
Secondary outcomes:
measure: Comparison of brainstem grey matter density between migraine with aura patients and controls with magnetic resonance imaging
timeFrame: 30 days after pre-inclusion visit
measure: Comparison of cerebral autoregulation between migraine with aura patients and controls with Transcranial Doppler
timeFrame: 30 days after pre-inclusion visit
measure: Comparison of cerebrovascular reactivity to carbon dioxide between migraine with aura patients and controls with Transcranial Doppler
timeFrame: 30 days after pre-inclusion visit
measure: Comparison of morphological abnormalities between migraine with aura patients and controls with resonance magnetic imaging.
timeFrame: 30 days after pre-inclusion visit
measure: Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
timeFrame: 30 days after pre-inclusion visit
measure: Association between grey matter density and morphological abnormalities on resonance magnetic imaging
timeFrame: 30 days after pre-inclusion visit
measure: Association between cerebral autoregulation and morphological abnormalities on magnetic resonance imaging
timeFrame: 30 days after pre-inclusion visit
measure: Relation between baroreflex sensitivity and cerebral autoregulation with Transcranial Doppler.
timeFrame: 30 days after pre-inclusion visit
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Vincent LARRUE, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.