Migraine With AuraMINOTAURENCT02708797
Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.
A study testing Magnetic resonance imaging and Transcranial Doppler in people with Migraine With Aura, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- Magnetic resonance imaging and Transcranial Doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.
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.
- Conditions
- Migraine With Aura
- Being tested
- Magnetic resonance imaging, Transcranial Doppler
- Keywords
- Cerebral autoregulation, MRI, VBM, Doppler Transcranial
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
Transcranial DopplerOther
Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
| Study group | Role | What they receive |
|---|---|---|
| Migraine with aura Patients | Other | Patients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler. Receives: Other: Magnetic resonance imaging; Other: Transcranial Doppler |
| Controls | Other | Control group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler. Receives: Other: Magnetic resonance imaging; Other: Transcranial Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison will be done with software using voxel based morphometry (VBM) function in addition of imaging with resonance magnetic imaging.
Measured: 30 days after pre-inclusion visit
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.
Measured: 30 days after pre-inclusion visit
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.
Measured: 30 days after pre-inclusion visit
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.
Measured: 30 days after pre-inclusion visit
Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
Measured: 30 days after pre-inclusion visit
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
Measured: 30 days after pre-inclusion visit
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
Measured: 30 days after pre-inclusion visit
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
Measured: 30 days after pre-inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent LARRUE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708797
- Sponsor's protocol ID
- RC31/15/7815
- Other IDs
- 2015-A01982-47
- Acronym
- MINOTAURE
- Status last verified
- Jul 2020
- First submitted
- 9 Mar 2016
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30296840Gollion 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.
PubMed 35982396
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura : a MRI and Transcranial Doppler.
- ClinicalTrials.gov ID
- NCT02708797
- Acronym / sponsor ID
- MINOTAURE / RC31/15/7815
- Conditions
- Migraine With Aura
- Keywords
- Cerebral autoregulation, MRI, VBM, Doppler Transcranial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine with aura Patients | Other | Other: Magnetic resonance imaging, Other: Transcranial DopplerPatients with migraine with aura will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler. |
| Controls | Other | Other: Magnetic resonance imaging, Other: Transcranial DopplerControl group with healthy volunteers will be studied 30 days after the pre inclusion visit with both magnetic resonance imaging and Transcranial Doppler. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingPatients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive. | Other | Controls, Migraine with aura Patients |
| Transcranial DopplerPatients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive. | Other | Controls, Migraine with aura Patients |
Primary outcome
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.
8 secondary outcomes
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 of cerebral autoregulation between migraine with aura patients and controls with Transcranial Doppler
Time frame: 30 days after pre-inclusion visit
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 of morphological abnormalities between migraine with aura patients and controls with resonance magnetic imaging.
Time frame: 30 days after pre-inclusion visit
Comparison of baroreflex sensitivity between migraine with aura patients and controls with Transcranial Doppler
Time frame: 30 days after pre-inclusion visit
Association between grey matter density and morphological abnormalities on resonance magnetic imaging
Time frame: 30 days after pre-inclusion visit
Association between cerebral autoregulation and morphological abnormalities on magnetic resonance imaging
Time frame: 30 days after pre-inclusion visit
Relation between baroreflex sensitivity and cerebral autoregulation with Transcranial Doppler.
Time frame: 30 days after pre-inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Results publication: PubMed 30296840Gollion 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.
- Derived from this study: PubMed 35982396Gollion 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent LARRUE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging and Transcranial Doppler in people with Migraine With Aura, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 days after the pre-inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.