Headache Versus Non-headache DayNCT01471314
MRA/fMRI Study of Spontaneous Migraine
An observational study of Headache Versus Non-headache Day, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following: Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache Versus Non-headache Day
- What is being tested?
- Headache day versus non-headache day
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Start not givento 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Migraine without aura
Who may be able to join
- Migraine without aura according to IHS criteria.
Who cannot join
- Other primary headaches.
- Tension-type headache more than 5 days/month.
- Use of anti-pain medication before the scanning on the examination day.
- Pregnant or nursing women.
- Contraindication for MR scan.
- Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse.
- Other clinical conditions assessed by the examining doctor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen
Glostrup Municipality, DK-2600
Faisal Amin, MD, PhD student, +4538633066, famoam01@regionh.dk
About this study
Official title: Functional MRI and MR Angiography Used in Spontaneous Migraine
The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:
- Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).
- Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).
- Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.
Read more
Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.
The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.
- Conditions
- Headache Versus Non-headache Day
- Being tested
- Headache day versus non-headache day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache day versus non-headache dayBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous migraine | Not described Receives: Behavioral: Headache day versus non-headache day |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (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 Headache Versus Non-headache DayStudies 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 only
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Principal investigator, Faisal Mohammad Amin, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471314
- Sponsor's protocol ID
- H-C-2008-089
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2011
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amin FM, Asghar MS, Hougaard A, Hansen AE, Larsen VA, de Koning PJ, Larsson HB, Olesen J, Ashina M. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013 May;12(5):454-61. doi: 10.1016/S1474-4422(13)70067-X. Epub 2013 Apr 9.
PubMed 23578775
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI and MR Angiography Used in Spontaneous Migraine
- ClinicalTrials.gov ID
- NCT01471314
- Acronym / sponsor ID
- H-C-2008-089
- Conditions
- Headache Versus Non-headache Day
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- First posted
- 15 Nov 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.
The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:
- Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).
- Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).
- Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.
Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.
The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous migraine | – | Behavioral: Headache day versus non-headache day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Migraine without aura
Key inclusion criteria (1 listed)
- Migraine without aura according to IHS criteria.
Key exclusion criteria (7 listed)
- Other primary headaches.
- Tension-type headache more than 5 days/month.
- Use of anti-pain medication before the scanning on the examination day.
- Pregnant or nursing women.
- Contraindication for MR scan.
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 |
|---|---|---|
| Headache day versus non-headache day | Behavioural | Spontaneous migraine |
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 29 Aug 2012.
- Derived from this study: PubMed 23578775Amin FM, Asghar MS, Hougaard A, Hansen AE, Larsen VA, de Koning PJ, Larsson HB, Olesen J, Ashina M. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013 May;12(5):454-61. doi: 10.1016/S1474-4422(13)70067-X. Epub 2013 Apr 9.
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 Headache Versus Non-headache Day, 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 1 inclusion and 7 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 Aug 2012. 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 Amin, MD, PhD student (+4538633066, famoam01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471314, 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 Aug 2012.