Migraine With AuraNCT02202486
Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
An observational study of Migraine With Aura and Migraine Without Aura, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- What is being tested?
- Brain MRI
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Dec 2015
- 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: Migraine patients.
Who may be able to join
- diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the International Headache Society.
- written informed consent.
- use of anticonceptive method by women in childbearing age.
Who cannot join
- tension type headache more than 5/month during last year.
- tension type headache on the experimental day.
- use of antimigraine medication or pain-killer on the experimental day before MRI.
- pregnant or breastfeeding women.
- contraindications against MRI.
- history or clinical sign of cardio- or cerebrovascular disease.
Show all 9Show fewer
- untreated severe mental disorder or drug abuse.
- other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
- not accepting information about potential accidental finding during experiment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center, Glostrup Hospital
Glostrup Municipality, Copenhagen, 2600
Faisal M Amin, MD, +4538633066, faisal.mohammad.amin.01@regionh.dk
About this study
Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI.
Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. What happens during migraine attacks has never been investigated. The hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional MRI.
Read more
Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with migraine with aura, but not in those without aura. We hypothesize that CBF is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (ASL).
Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been suggested but never investigated during migraine attacks. Our hypothesis is that pain related structures show altered VBM during spontaneous migraine attacks.
Read the detailed description
Brain MRI during and outside migraine attacks.
Up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks.
The study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.
- Conditions
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Being tested
- Brain MRI
- Medical subject headings
- Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
Brain MRI with gadolinium contrast
| Study group | Role | What they receive |
|---|---|---|
| Migraine with aura | Brain MRI Receives: Other: Brain MRI | |
| Migraine without aura | Brain MRI Receives: Other: Brain MRI | |
| Chronic migraine | Brain MRI Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-brain barrier alteration during migraine attacks
Measured: Up to 1 year
Cerebral blood flow alteration during migraine attacks
Measured: Up to 1 year
Resting-state functional brain connectivity alteration during migraine attacks
Measured: Up to 1 year
Voxel-based morphometry alteration during migraine attacks
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startSep 2012
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen
- Investigators
- Faisal M Amin, MD, Principal investigator, Danish Headache Center, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202486
- Sponsor's protocol ID
- H-3-2012-073
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amin FM, De Icco R, Al-Karagholi MA, Raghava JM, Wolfram F, Larsson HBW, Ashina M. Investigation of cortical thickness and volume during spontaneous attacks of migraine without aura: a 3-Tesla MRI study. J Headache Pain. 2021 Aug 21;22(1):98. doi: 10.1186/s10194-021-01312-9.
PubMed 34418951
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI
- ClinicalTrials.gov ID
- NCT02202486
- Acronym / sponsor ID
- H-3-2012-073
- Conditions
- Migraine With Aura, Migraine Without Aura, Chronic Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Jul 2014 (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.
Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using MRI.
Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. What happens during migraine attacks has never been investigated. The hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional MRI.
Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with migraine with aura, but not in those without aura. We hypothesize that CBF is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (ASL).
Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been suggested but never investigated during migraine attacks. Our hypothesis is that pain related structures show altered VBM during spontaneous migraine attacks.
Detailed description
Brain MRI during and outside migraine attacks.
Up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks.
The study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Migraine with aura | – | Other: Brain MRIBrain MRI |
| Migraine without aura | – | Other: Brain MRIBrain MRI |
| Chronic migraine | – | Other: Brain MRIBrain MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine patients.
Key inclusion criteria (3 listed)
- diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the International Headache Society.
- written informed consent.
- use of anticonceptive method by women in childbearing age.
Key exclusion criteria (9 listed)
- tension type headache more than 5/month during last year.
- tension type headache on the experimental day.
- use of antimigraine medication or pain-killer on the experimental day before MRI.
- pregnant or breastfeeding women.
- contraindications against MRI.
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 |
|---|---|---|
| Brain MRIBrain MRI with gadolinium contrast | Other | Chronic migraine, Migraine with aura, Migraine without aura |
Primary outcome
Blood-brain barrier alteration during migraine attacks
Time frame: Up to 1 year
Cerebral blood flow alteration during migraine attacks
Time frame: Up to 1 year
Resting-state functional brain connectivity alteration during migraine attacks
Time frame: Up to 1 year
Voxel-based morphometry alteration during migraine attacks
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Derived from this study: PubMed 34418951Amin FM, De Icco R, Al-Karagholi MA, Raghava JM, Wolfram F, Larsson HBW, Ashina M. Investigation of cortical thickness and volume during spontaneous attacks of migraine without aura: a 3-Tesla MRI study. J Headache Pain. 2021 Aug 21;22(1):98. doi: 10.1186/s10194-021-01312-9.
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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.
Faisal M Amin, MD principal investigator
Danish Headache Center, Glostrup 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 Migraine With Aura and Migraine Without 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 9 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 29 Jul 2014. 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 Faisal M Amin, MD (+4538633066, faisal.mohammad.amin.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-brain barrier alteration during migraine attacks (time frame: Up to 1 year). The study lists 4 primary outcomes in all. 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 NCT02202486, which also lists 1 linked publication.
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 2014.