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

Not Applicable

Completed

• Conditions: Headache; Aura; Migraine
• Interventions: Other: Hypoxia; Other: Placebo

• Registration Number: NCT01896167
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypoxia	Hypoxia	Inhalation of air with 8-12% oxygen content
Atmospheric air	Placebo	Inhalation of atmospheric air, with oxygen content at 21%

Primary Outcome Measures

Name	Time	Method
Headache and aura	24 h	Comparison between hypoxia and placebo (atmospheric air)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanna Arngrim; 🇩🇰 Glostrup, Denmark