EmergenciesPERCAMNCT03821584
Brain Perfusion Assessment in the Acute Phase of Migraine Aura
An observational study of Emergencies, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 22 Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital with neurological deficit and final clinical diagnosis of migraine with aura (certain probable as defined by The International Classification of Headache Disorders)
Who may be able to join
- Age between greater than or equal to 18
- Able to undergo MRI during migraine aura
Who cannot join
- Pregnant females
- Contraindications towards MRI scanning
- History of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..).
- Presence of abnormalities on the MRI that could explain the neurological deficit.
- Adults under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Perfusion Assessment in the Acute Phase of Migraine Aura.
The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.
Read the detailed description
Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal neurological symptoms developing gradually during attack. Its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. Thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. Considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. MRI with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion method, will be used to describe brain perfusion during migraine aura. The study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.
- Conditions
- Emergencies
- Being tested
- the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
- Keywords
- migraine, perfusion arterial, aura brain
- Medical subject headings
- Emergencies, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interestOther
the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion pattern of concerned brain areas
Presence or absence of hypo-hyperperfusion using arterial spin labeling. Visual assessments and comparison between hemispheres
Measured: 1 hour
Secondary outcomes (1)
Pattern of perfusion and aura duration
Change in brain perfusion in relation to neurological deficits (migraine aura) duration.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Mar 2019
- Primary completion22 Jun 2021
- Study completion22 Jul 2021
Why it stopped: Recruiting terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solene de Gaalon, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821584
- Sponsor's protocol ID
- RC18_0373
- Acronym
- PERCAM
- Status last verified
- Jul 2021
- First submitted
- 4 Jan 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Perfusion Assessment in the Acute Phase of Migraine Aura.
- ClinicalTrials.gov ID
- NCT03821584
- Acronym / sponsor ID
- PERCAM / RC18_0373
- Conditions
- Emergencies
- Keywords
- migraine, perfusion arterial, aura brain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruiting terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 30 Jan 2019 (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.
The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.
Detailed description
Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal neurological symptoms developing gradually during attack. Its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. Thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. Considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. MRI with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion method, will be used to describe brain perfusion during migraine aura. The study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with neurological deficit and final clinical diagnosis of migraine with aura (certain probable as defined by The International Classification of Headache Disorders)
Key inclusion criteria (2 listed)
- Age between greater than or equal to 18
- Able to undergo MRI during migraine aura
Key exclusion criteria (5 listed)
- Pregnant females
- Contraindications towards MRI scanning
- History of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..).
- Presence of abnormalities on the MRI that could explain the neurological deficit.
- Adults under guardianship or trusteeship
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 |
|---|---|---|
| the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interestthe difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest | Other | – |
Primary outcome
Perfusion pattern of concerned brain areas
Time frame: 1 hour
Presence or absence of hypo-hyperperfusion using arterial spin labeling. Visual assessments and comparison between hemispheres
1 secondary outcome
Pattern of perfusion and aura duration
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Recruiting terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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.
Solene de Gaalon, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Nantes University Hospital 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: stopped early, as of the sponsor's last update on 17 Sep 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.
Are results available for this study?
The study was stopped early (reason given: Recruiting terminated). Results are not available in the source record.
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?
Perfusion pattern of concerned brain areas (time frame: 1 hour). 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 17 Sep 2021.