Migraine AuraPhase 4MARIENCT03689361
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
A Phase 4 study testing MRI and telephone consultation in people with Migraine Aura, run by University Hospital, Toulouse at 1 site in France.
Trial summary
investigators hypothesize that T2 * vein abnormalities are frequent and are specific to the migraine aura. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine Aura
- What is being tested?
- MRI and telephone consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2018to 11 Dec 2020
- Phase
- Phase 4
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 55 years
- Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI
- less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission
- less than two hours after the disappearance of symptoms if the patient arrives asymptomatic
- Affiliated to a social protection scheme.
- Having given their informed consent
Who cannot join
- Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness
- Presence of recent explanatory abnormalities on the MRI to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations).
- Potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation.
- Pregnant women - Patients with a contraindication for MRI.
- Patients benefiting from a system of legal protection (tutelage,
Trial locations and contacts
1 site in 1 country.
About this study
investigators hypothesize that T2 * vein abnormalities are frequent and are specific to the migraine aura.
Read the detailed description
The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. The possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2 *, would be an important advance for the management of these patients
- Conditions
- Migraine Aura
- Being tested
- MRI, MRI control, telephone consultation
- Keywords
- migraine aura
- 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.
MRICombination product
Routine MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion).
MRI controlDiagnostic test
MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion)
telephone consultationOther
telephone consultation
| Study group | Role | What they receive |
|---|---|---|
| with migraine aura. | Other | patient with migraine aura detected by MRI, then MRI control 3 month after Receives: Combination Product: MRI; Diagnostic Test: MRI control |
| without migraine aura | Other | patient without migraine aura detected by MRI, then telephone consultation 3 month after Receives: Other: telephone consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of the presence of visible brain vein abnormalities
visible brain vein abnormalities on T2 * sequences MRI ,
Measured: Day 0
Secondary outcomes (2)
perfusion parameters
in MRI , Overall visual assessment: presence or absence of hypoperfusion (presence or not in each anterior, middle and posterior territory) each lobe: Frontal, Temporal, Parietal, Occipital)
Measured: Day 0
asymmetry of visualization of the 3 intracranial arteries in MRI
in MRI TOF
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start22 Dec 2018
- Primary completion11 Oct 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Viguier, PH, Principal investigator, Uuniversity Hospital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689361
- Sponsor's protocol ID
- RC31/16/8249
- Other IDs
- 2017-004091-60, 2017
- Acronym
- MARIE
- Status last verified
- Feb 2021
- First submitted
- 20 Sep 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
- ClinicalTrials.gov ID
- NCT03689361
- Acronym / sponsor ID
- MARIE / RC31/16/8249
- Conditions
- Migraine Aura
- Keywords
- migraine aura
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
investigators hypothesize that T2 * vein abnormalities are frequent and are specific to the migraine aura.
Detailed description
The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. The possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2 *, would be an important advance for the management of these patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with migraine aura. | Other | Combination Product: MRI, Diagnostic Test: MRI controlpatient with migraine aura detected by MRI, then MRI control 3 month after |
| without migraine aura | Other | Other: telephone consultationpatient without migraine aura detected by MRI, then telephone consultation 3 month after |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18 to 55 years
- Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI
- Affiliated to a social protection scheme.
- Having given their informed consent
Key exclusion criteria (5 listed)
- Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness
- Presence of recent explanatory abnormalities on the MRI to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations).
- Potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation.
- Pregnant women - Patients with a contraindication for MRI.
- Patients benefiting from a system of legal protection (tutelage,
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 |
|---|---|---|
| MRIRoutine MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion). | Combination product | with migraine aura. |
| MRI controlMRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion) | Diagnostic test | with migraine aura. |
| telephone consultationtelephone consultation | Other | without migraine aura |
Primary outcome
frequency of the presence of visible brain vein abnormalities
Time frame: Day 0
visible brain vein abnormalities on T2 * sequences MRI ,
2 secondary outcomes
perfusion parameters
Time frame: Day 0
asymmetry of visualization of the 3 intracranial arteries in MRI
Time frame: Day 0
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 3 Feb 2021.
- 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.
Alain Viguier, PH principal investigator
Uuniversity Hospital Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MRI and telephone consultation in people with Migraine 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 6 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 3 Feb 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
frequency of the presence of visible brain vein abnormalities (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.