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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01896167
First received: June 21, 2013
Last updated: February 11, 2015
Last verified: February 2015
  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: Double Blind (Subject, Caregiver, 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 Danish Headache Center:

Primary Outcome Measures:
  • Headache and aura [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    Comparison between hypoxia and placebo (atmospheric air)


Secondary Outcome Measures:
  • artery circumference [ Time Frame: Baseline, 120 and 200 min ] [ Designated as safety issue: No ]
    Hypoxia induced changes in intra- and extracranial circumference

  • Cerebral blood flow [ Time Frame: Baseline, 120 and 200 min ] [ Designated as safety issue: No ]
    Hypoxia induced changes in cerebral blood flow

  • BOLD response in visual cortex [ Time Frame: Baseline, 170 min and 220 min ] [ Designated as safety issue: No ]
    Hypoxia induced changes in BOLD response

  • Brain metabolism [ Time Frame: Baseline, 180 min and 230 min post hypoxia ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 21, 2013
Last Updated: February 11, 2015
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
Headache
Migraine
Aura
Cerebral hemodynamics

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on May 29, 2015