Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.

Migraine With Aura Clinical Trial

— MINOTAURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708797
• Other study ID #: RC31/15/7815
• Secondary ID: 2015-A01982-47
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Gollion C, Nasr N, Fabre N, Barège 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after the pre-inclusion visit
Secondary	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.	30 days after pre-inclusion visit
Secondary	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.	30 days after pre-inclusion visit
Secondary	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.	30 days after pre-inclusion visit
Secondary	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.	30 days after pre-inclusion visit
Secondary	Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler		30 days after pre-inclusion visit
Secondary	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	30 days after pre-inclusion visit
Secondary	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	30 days after pre-inclusion visit
Secondary	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	30 days after pre-inclusion visit