Migraine With AuraNCT01388894
Functional MRI and MRA in Migraine With Aura
An observational study of Migraine With Aura, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine With Aura
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with migraine with aura
Who may be able to join
- Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2
- Age between 18 and 80 years both inclusive
- Reports that bright light or strenuous physical activity may trigger migraine aura
Who cannot join
- Contraindications towards exposure to photostimulation or strenuous exercise
- Body weight above 130 kg
- Pregnant or lactating females
- Contraindications towards MRI scanning
- History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality, 2600
Anders Hougaard, MD, +4538632713, andhou05@glo.regionh.dk
Anders Hougaard, MD
About this study
Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.
- Conditions
- Migraine With Aura
- Medical subject headings
- Migraine with Aura
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388894
- Sponsor's protocol ID
- MA-01
- Status last verified
- May 2011
- First submitted
- 5 Jul 2011
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI and MRA in Migraine With Aura
- ClinicalTrials.gov ID
- NCT01388894
- Acronym / sponsor ID
- MA-01
- Conditions
- Migraine With Aura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Dec 2010
- First posted
- 7 Jul 2011 (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.
Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with migraine with aura
Key inclusion criteria (3 listed)
- Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2
- Age between 18 and 80 years both inclusive
- Reports that bright light or strenuous physical activity may trigger migraine aura
Key exclusion criteria (5 listed)
- Contraindications towards exposure to photostimulation or strenuous exercise
- Body weight above 130 kg
- Pregnant or lactating females
- Contraindications towards MRI scanning
- History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2011.
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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.
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 Migraine With Aura, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Jul 2011. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Hougaard, MD (+4538632713, andhou05@glo.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Jul 2011.