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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Danish Headache Center
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01896167
First received: June 21, 2013
Last updated: September 10, 2013
Last verified: September 2013
  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 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, 90 and 180 min ] [ Designated as safety issue: No ]
    Hypoxia induced changes in intra- and extracranial circumference

  • Cerebral blood flow [ Time Frame: Baseline, 90 and 180 min ] [ Designated as safety issue: No ]
    Hypoxia induced changes in cerebral blood flow

  • Resting state functional connectivity [ Time Frame: Baseline and approximately 15 min post hypoxia ] [ Designated as safety issue: No ]
    To identify specific patterns in resting state functional connectivity (RSFC) in the pre-ictal stage of a migraine attack induced by hypoxia


Estimated Enrollment: 12
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine with aura patients
  • 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
  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

Contacts
Contact: Nanna Arngrim, MD 004538634612 nanna.bjoerkbom.arngrim.01@regionh.dk

Locations
Denmark
Nanna Arngrim Recruiting
Glostrup, Denmark, 2600
Contact: Nanna Arngrim, MD    00 45 38 63 46 12    nanna.bjoerkbom.arngrim.01@regionh.dk   
Principal Investigator: Nanna Arngrim, MD         
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: September 10, 2013
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
Headache
Anoxia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 14, 2014