Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.
MINOTAURE
2 other identifiers
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJuly 29, 2020
July 1, 2020
11 months
March 9, 2016
July 28, 2020
Conditions
Keywords
Outcome Measures
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.
Resonance magnetic imaging use voxel base morphometry and Transcranial doppler use the coefficient mx calculation.
30 days after the pre-inclusion visit
Secondary Outcomes (8)
Comparison of brainstem grey matter density between migraine with aura patients and controls with magnetic resonance imaging
30 days after pre-inclusion visit
Comparison of cerebral autoregulation between migraine with aura patients and controls with Transcranial Doppler
30 days after pre-inclusion visit
Comparison of cerebrovascular reactivity to carbon dioxide between migraine with aura patients and controls with Transcranial Doppler
30 days after pre-inclusion visit
Comparison of morphological abnormalities between migraine with aura patients and controls with resonance magnetic imaging.
30 days after pre-inclusion visit
Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
30 days after pre-inclusion visit
- +3 more secondary outcomes
Study Arms (2)
Migraine with aura Patients
OTHERPatients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Controls
OTHERControl group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler.
Interventions
Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse
Toulouse, France
Related Publications (2)
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.
PMID: 30296840RESULTGollion 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.
PMID: 35982396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent LARRUE, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 15, 2016
Study Start
May 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share