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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Headache, Migraine, Aura

Intervention / Treatment
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* Other: Hypoxia
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 exclusion Criteria for healthy volunteers: migraine at present or earlier in life parents, sibling or children who suffer or have suffered from migraine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypoxia<br>Inhalation of air with 8-12% oxygen content | Other: Hypoxia<br>* Inhalation of hypoxic air (8-12% oxygen content)<br>|
| Placebo Comparator: Atmospheric air<br>Inhalation of atmospheric air, with oxygen content at 21% | Other: Placebo<br>* Inhalation of atmospheric air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache and aura | Comparison between hypoxia and placebo (atmospheric air) | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| artery circumference | Hypoxia induced changes in intra- and extracranial circumference | Baseline, 120 and 200 min | 
| Cerebral blood flow | Hypoxia induced changes in cerebral blood flow | Baseline, 120 and 200 min | 
| BOLD response in visual cortex | Hypoxia induced changes in BOLD response | Baseline, 170 min and 220 min | 
| Brain metabolism | Hypoxia induced changes in brain metabolism | Baseline, 180 min and 230 min post hypoxia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Migraine, Aura, Cerebral hemodynamics