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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01896167
First Posted: July 11, 2013
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
  Purpose

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.

Condition Intervention
Headache Migraine Aura Other: Hypoxia Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model

Resource links provided by NLM:


Further study details as provided by Nanna Arngrim, Danish Headache Center:

Primary Outcome Measures:
  • Headache and aura [ Time Frame: 24 h ]
    Comparison between hypoxia and placebo (atmospheric air)


Secondary Outcome Measures:
  • artery circumference [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in intra- and extracranial circumference

  • Cerebral blood flow [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in cerebral blood flow

  • BOLD response in visual cortex [ Time Frame: Baseline, 170 min and 220 min ]
    Hypoxia induced changes in BOLD response

  • Brain metabolism [ Time Frame: Baseline, 180 min and 230 min post hypoxia ]
    Hypoxia induced changes in brain metabolism


Enrollment: 34
Study Start Date: April 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hypoxia
Inhalation of air with 8-12% oxygen content
Other: Hypoxia
Inhalation of hypoxic air (8-12% oxygen content)
Placebo Comparator: Atmospheric air
Inhalation of atmospheric air, with oxygen content at 21%
Other: Placebo
Inhalation of atmospheric air

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896167


Locations
Denmark
Nanna Arngrim
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Nanna Arngrim, MD Department of Neurology, Glostrup Hospital
  More Information

Responsible Party: Nanna Arngrim, MD, medical doctors, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01896167     History of Changes
Other Study ID Numbers: H-4-2012-182
First Submitted: June 21, 2013
First Posted: July 11, 2013
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Nanna Arngrim, Danish Headache Center:
Headache
Migraine
Aura
Cerebral hemodynamics

Additional relevant MeSH terms:
Migraine Disorders
Headache
Hypoxia
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Respiratory