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Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia

Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01896167
Enrollment
34
Registered
2013-07-11
Start date
2013-04-30
Completion date
2014-09-30
Last updated
2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aura, Headache, Migraine

Keywords

Headache, Migraine, Aura, Cerebral hemodynamics

Brief 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 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.

Interventions

OTHERHypoxia

Inhalation of hypoxic air (8-12% oxygen content)

OTHERPlacebo

Inhalation of atmospheric air

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Migraine with aura patients and Helthy volunteers as controls: * Aged 18-40 * 50-100 kg

Exclusion criteria

* 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 * Hypertension * Hypotension * Respiratory or cardiac disease * smoking Extra

Design outcomes

Primary

MeasureTime frameDescription
Headache and aura24 hComparison between hypoxia and placebo (atmospheric air)

Secondary

MeasureTime frameDescription
artery circumferenceBaseline, 120 and 200 minHypoxia induced changes in intra- and extracranial circumference
Cerebral blood flowBaseline, 120 and 200 minHypoxia induced changes in cerebral blood flow
BOLD response in visual cortexBaseline, 170 min and 220 minHypoxia induced changes in BOLD response
Brain metabolismBaseline, 180 min and 230 min post hypoxiaHypoxia induced changes in brain metabolism

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026