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Completed

NCT Number: NCT01896167

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

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.

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Key information

Conditions

Headache Aura Brain Diseases Central Nervous System Diseases Epilepsy Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanna Arngrim

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia

Other

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

Placebo

Other

Inhalation of atmospheric air

Primary outcomes

  1. Headache and aura

    Time frame: 24 h

    Comparison between hypoxia and placebo (atmospheric air)

Secondary outcomes

  1. artery circumference

    Time frame: Baseline, 120 and 200 min

    Hypoxia induced changes in intra- and extracranial circumference

  2. Cerebral blood flow

    Time frame: Baseline, 120 and 200 min

    Hypoxia induced changes in cerebral blood flow

  3. BOLD response in visual cortex

    Time frame: Baseline, 170 min and 220 min

    Hypoxia induced changes in BOLD response

  4. Brain metabolism

    Time frame: Baseline, 180 min and 230 min post hypoxia

    Hypoxia induced changes in brain metabolism

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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