MigraineOPAMANCT03536936
Oxygenation and Perfusion in Patients With Acute Migraine Attacks
An observational study of Migraine and Migraine With Aura, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
The aim of the study is to retrospectively evaluate brain perfusion and oxygenation in acute migraine attacks. Magnetic resonance perfusion and susceptibility weighted imaging are the technics to measure perfusion and oxygenation respectively. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine; Status
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Apr 2018
- 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 6 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who present to hospital emergency with acute symptoms of stroke, undergo MR imaging to exclude stroke or other stroke mimics, and at discharge have confirmed diagnosis of acute migraine attack.
Who may be able to join
- final clinical diagnosis of migraine
Who cannot join
- brain tumors, seizures/epilepsy, confirmed cerebral infarct from cerebral atery occlusion, sinus vein thrombosis;
About this study
The aim of the study is to retrospectively evaluate brain perfusion and oxygenation in acute migraine attacks. Magnetic resonance perfusion and susceptibility weighted imaging are the technics to measure perfusion and oxygenation respectively.
Read the detailed description
The aim of the study is to demonstrate a possible correlation between areas of hypoperfusion and prominent cortical veins during migraine attacks.
These focal ares of altered vascular supply of the brain will be evaluated for correlation with topograhy of symptoms.
- Conditions
- Migraine, Migraine With Aura, Migraine; Status
- Medical subject headings
- Migraine Disorders, Migraine with Aura
What is being measured
The primary outcome is the main question the study is designed to answer.
Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack
Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack, measured with visual scores on imaging, using a consensus between two readers
Measured: Patients, who are admitted to hospital, undergo magnetic resonance imaging within 5 days of migraine attack; time frame: symptoms to imaging : 5 days;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jan 2010
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536936
- Sponsor's protocol ID
- Migraine Brain Perfusion
- Acronym
- OPAMA
- Status last verified
- May 2018
- First submitted
- 14 May 2018
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosemani T, Burton VJ, Felling RJ, Leigh R, Oakley C, Poretti A, Huisman TA. Pediatric hemiplegic migraine: role of multiple MRI techniques in evaluation of reversible hypoperfusion. Cephalalgia. 2014 Apr;34(4):311-5. doi: 10.1177/0333102413509432. Epub 2013 Oct 18.
PubMed 24142848Charles A, Brennan KC. The neurobiology of migraine. Handb Clin Neurol. 2010;97:99-108. doi: 10.1016/S0072-9752(10)97007-3.
PubMed 20816413Fedak EM, Zumberge NA, Heyer GL. The diagnostic role for susceptibility-weighted MRI during sporadic hemiplegic migraine. Cephalalgia. 2013 Nov;33(15):1258-63. doi: 10.1177/0333102413491027. Epub 2013 Jun 13.
PubMed 23766355Floery D, Vosko MR, Fellner FA, Fellner C, Ginthoer C, Gruber F, Ransmayr G, Doerfler A, Uder M, Bradley WG. Acute-onset migrainous aura mimicking acute stroke: MR perfusion imaging features. AJNR Am J Neuroradiol. 2012 Sep;33(8):1546-52. doi: 10.3174/ajnr.A3020. Epub 2012 Apr 19.
PubMed 22517281Forster A, Wenz H, Kerl HU, Brockmann MA, Groden C. Perfusion patterns in migraine with aura. Cephalalgia. 2014 Oct;34(11):870-6. doi: 10.1177/0333102414523339. Epub 2014 Feb 19.
PubMed 24554619Kao HW, Tsai FY, Hasso AN. Predicting stroke evolution: comparison of susceptibility-weighted MR imaging with MR perfusion. Eur Radiol. 2012 Jul;22(7):1397-403. doi: 10.1007/s00330-012-2387-4. Epub 2012 Feb 10.
PubMed 22322311Launer LJ, Terwindt GM, Ferrari MD. The prevalence and characteristics of migraine in a population-based cohort: the GEM study. Neurology. 1999 Aug 11;53(3):537-42. doi: 10.1212/wnl.53.3.537.
PubMed 10449117Mourand I, Menjot de Champfleur N, Carra-Dalliere C, Le Bars E, Roubertie A, Bonafe A, Thouvenot E. Perfusion-weighted MR imaging in persistent hemiplegic migraine. Neuroradiology. 2012 Mar;54(3):255-60. doi: 10.1007/s00234-011-0946-z. Epub 2011 Aug 11.
PubMed 21833737Planche V, Chassin O, Leduc L, Regnier W, Kelly A, Colamarino R. Sturge-Weber syndrome with late onset hemiplegic migraine-like attacks and progressive unilateral cerebral atrophy. Cephalalgia. 2014 Jan;34(1):73-7. doi: 10.1177/0333102413505237. Epub 2013 Sep 17.
PubMed 24045571
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation and Perfusion in Patients With Acute Migraine Attacks
- ClinicalTrials.gov ID
- NCT03536936
- Acronym / sponsor ID
- OPAMA / Migraine Brain Perfusion
- Conditions
- Migraine, Migraine With Aura, Migraine; Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 25 May 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.
The aim of the study is to retrospectively evaluate brain perfusion and oxygenation in acute migraine attacks. Magnetic resonance perfusion and susceptibility weighted imaging are the technics to measure perfusion and oxygenation respectively.
Detailed description
The aim of the study is to demonstrate a possible correlation between areas of hypoperfusion and prominent cortical veins during migraine attacks.
These focal ares of altered vascular supply of the brain will be evaluated for correlation with topograhy of symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present to hospital emergency with acute symptoms of stroke, undergo MR imaging to exclude stroke or other stroke mimics, and at discharge have confirmed diagnosis of acute migraine attack.
Key inclusion criteria (1 listed)
- final clinical diagnosis of migraine
Key exclusion criteria (1 listed)
- brain tumors, seizures/epilepsy, confirmed cerebral infarct from cerebral atery occlusion, sinus vein thrombosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack
Time frame: Patients, who are admitted to hospital, undergo magnetic resonance imaging within 5 days of migraine attack; time frame: symptoms to imaging : 5 days;
Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack, measured with visual scores on imaging, using a consensus between two readers
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 25 May 2018.
- Results publication: PubMed 24142848Bosemani T, Burton VJ, Felling RJ, Leigh R, Oakley C, Poretti A, Huisman TA. Pediatric hemiplegic migraine: role of multiple MRI techniques in evaluation of reversible hypoperfusion. Cephalalgia. 2014 Apr;34(4):311-5. doi: 10.1177/0333102413509432. Epub 2013 Oct 18.
- Results publication: PubMed 20816413Charles A, Brennan KC. The neurobiology of migraine. Handb Clin Neurol. 2010;97:99-108. doi: 10.1016/S0072-9752(10)97007-3.
- Results publication: PubMed 23766355Fedak EM, Zumberge NA, Heyer GL. The diagnostic role for susceptibility-weighted MRI during sporadic hemiplegic migraine. Cephalalgia. 2013 Nov;33(15):1258-63. doi: 10.1177/0333102413491027. Epub 2013 Jun 13.
- Results publication: PubMed 22517281Floery D, Vosko MR, Fellner FA, Fellner C, Ginthoer C, Gruber F, Ransmayr G, Doerfler A, Uder M, Bradley WG. Acute-onset migrainous aura mimicking acute stroke: MR perfusion imaging features. AJNR Am J Neuroradiol. 2012 Sep;33(8):1546-52. doi: 10.3174/ajnr.A3020. Epub 2012 Apr 19.
- Results publication: PubMed 24554619Forster A, Wenz H, Kerl HU, Brockmann MA, Groden C. Perfusion patterns in migraine with aura. Cephalalgia. 2014 Oct;34(11):870-6. doi: 10.1177/0333102414523339. Epub 2014 Feb 19.
- Results publication: PubMed 22322311Kao HW, Tsai FY, Hasso AN. Predicting stroke evolution: comparison of susceptibility-weighted MR imaging with MR perfusion. Eur Radiol. 2012 Jul;22(7):1397-403. doi: 10.1007/s00330-012-2387-4. Epub 2012 Feb 10.
- Results publication: PubMed 10449117Launer LJ, Terwindt GM, Ferrari MD. The prevalence and characteristics of migraine in a population-based cohort: the GEM study. Neurology. 1999 Aug 11;53(3):537-42. doi: 10.1212/wnl.53.3.537.
- Results publication: PubMed 21833737Mourand I, Menjot de Champfleur N, Carra-Dalliere C, Le Bars E, Roubertie A, Bonafe A, Thouvenot E. Perfusion-weighted MR imaging in persistent hemiplegic migraine. Neuroradiology. 2012 Mar;54(3):255-60. doi: 10.1007/s00234-011-0946-z. Epub 2011 Aug 11.
- Results publication: PubMed 24045571Planche V, Chassin O, Leduc L, Regnier W, Kelly A, Colamarino R. Sturge-Weber syndrome with late onset hemiplegic migraine-like attacks and progressive unilateral cerebral atrophy. Cephalalgia. 2014 Jan;34(1):73-7. doi: 10.1177/0333102413505237. Epub 2013 Sep 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine With Aura, run by Insel Gruppe AG, University Hospital Bern.
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 1 inclusion and 1 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 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Focal cerebral hypoperfusion and elevated oxygenation in acute migraine attack (time frame: Patients, who are admitted to hospital, undergo magnetic resonance imaging within 5 days of migraine attack; time frame: symptoms to imaging : 5 days;). 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 NCT03536936, which also lists 9 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 25 May 2018.