HeadacheNCT01896167
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
A study testing Hypoxia in people with Headache and Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
In this study the investigators will investigate the following hypothesis that hypoxia induce migraine headache and migraine aura the aura phase is associated with a spreading reduction in cerebral blood flow the migraine headache is associated with dilatation of intra- and extracerebral arteries the migraine headache… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Sep 2014
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Migraine with aura patients and Helthy volunteers as controls:
- Aged 18-40
- 50-100 kg
Who cannot join
- Tension type headache more than 5 days/month
- Other primary headaches
- Daily medication except contraceptives
- Drug taken within 4 times the halflife for the specific drug except contraceptives
- Pregnant or lactating women
- Headache or migraine attack within the last 48 hours before start of trial
Show all 13Show fewer
- Hypertension
- Hypotension
- Respiratory or cardiac disease
- smoking
- Extra exclusion Criteria for healthy volunteers:
- migraine at present or earlier in life
- parents, sibling or children who suffer or have suffered from migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
In this study the investigators will investigate the following hypothesis
- that hypoxia induce migraine headache and migraine aura
- the aura phase is associated with a spreading reduction in cerebral blood flow
- the migraine headache is associated with dilatation of intra- and extracerebral arteries
- the migraine headache is associated with changes in brain metabolism
- the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.
Read the detailed description
To investigate migraine with aura symptoms during and after hypoxia.
With magnetic resonance imaging the investigators will investigate changes in
- regional cerebral blood flow (rCBF)
- resting state functional connectivity
- circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery
- brain metabolism
And compare these changes with a aged match healthy control group.
- Being tested
- Hypoxia, Placebo
- Keywords
- Headache, Migraine, Aura, Cerebral hemodynamics
- Medical subject headings
- Headache, Migraine Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
Inhalation of hypoxic air (8-12% oxygen content)
PlaceboOther
Inhalation of atmospheric air
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Active comparator | Inhalation of air with 8-12% oxygen content Receives: Other: Hypoxia |
| Atmospheric air | Placebo comparator | Inhalation of atmospheric air, with oxygen content at 21% Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache and aura
Comparison between hypoxia and placebo (atmospheric air)
Measured: 24 h
Secondary outcomes (4)
artery circumference
Hypoxia induced changes in intra- and extracranial circumference
Measured: Baseline, 120 and 200 min
Cerebral blood flow
Hypoxia induced changes in cerebral blood flow
Measured: Baseline, 120 and 200 min
BOLD response in visual cortex
Hypoxia induced changes in BOLD response
Measured: Baseline, 170 min and 220 min
Brain metabolism
Hypoxia induced changes in brain metabolism
Measured: Baseline, 180 min and 230 min post hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanna Arngrim, Danish Headache Center
- Investigators
- Nanna Arngrim, MD, Principal investigator, Department of Neurology, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896167
- Sponsor's protocol ID
- H-4-2012-182
- Status last verified
- Feb 2015
- First submitted
- 21 Jun 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
- ClinicalTrials.gov ID
- NCT01896167
- Acronym / sponsor ID
- H-4-2012-182
- Keywords
- Headache, Migraine, Aura, Cerebral hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jul 2013 (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.
In this study the investigators will investigate the following hypothesis
- that hypoxia induce migraine headache and migraine aura
- the aura phase is associated with a spreading reduction in cerebral blood flow
- the migraine headache is associated with dilatation of intra- and extracerebral arteries
- the migraine headache is associated with changes in brain metabolism
- the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.
Detailed description
To investigate migraine with aura symptoms during and after hypoxia.
With magnetic resonance imaging the investigators will investigate changes in
- regional cerebral blood flow (rCBF)
- resting state functional connectivity
- circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery
- brain metabolism
And compare these changes with a aged match healthy control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Active comparator | Other: HypoxiaInhalation of air with 8-12% oxygen content |
| Atmospheric air | Placebo comparator | Other: PlaceboInhalation of atmospheric air, with oxygen content at 21% |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40
- 50-100 kg
Key exclusion criteria (13 listed)
- Tension type headache more than 5 days/month
- Other primary headaches
- Daily medication except contraceptives
- Drug taken within 4 times the halflife for the specific drug except contraceptives
- Pregnant or lactating women
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 |
|---|---|---|
| HypoxiaInhalation of hypoxic air (8-12% oxygen content) | Other | Hypoxia |
| PlaceboInhalation of atmospheric air | Other | Atmospheric air |
Primary outcome
Headache and aura
Time frame: 24 h
Comparison between hypoxia and placebo (atmospheric air)
4 secondary outcomes
artery circumference
Time frame: Baseline, 120 and 200 min
Cerebral blood flow
Time frame: Baseline, 120 and 200 min
BOLD response in visual cortex
Time frame: Baseline, 170 min and 220 min
Brain metabolism
Time frame: Baseline, 180 min and 230 min post hypoxia
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 12 Feb 2015.
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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.
Nanna Arngrim, MD principal investigator
Department of Neurology, Glostrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia in people with Headache and Migraine, run by Danish Headache Center 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 13 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 12 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Headache and aura (time frame: 24 h). 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 12 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.