Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Primary Purpose
Headache, Migraine, Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hypoxia
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Headache focused on measuring Headache, Migraine, Aura, Cerebral hemodynamics
Eligibility 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
Sites / Locations
- Nanna Arngrim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hypoxia
Atmospheric air
Arm Description
Inhalation of air with 8-12% oxygen content
Inhalation of atmospheric air, with oxygen content at 21%
Outcomes
Primary Outcome Measures
Headache and aura
Comparison between hypoxia and placebo (atmospheric air)
Secondary Outcome Measures
artery circumference
Hypoxia induced changes in intra- and extracranial circumference
Cerebral blood flow
Hypoxia induced changes in cerebral blood flow
BOLD response in visual cortex
Hypoxia induced changes in BOLD response
Brain metabolism
Hypoxia induced changes in brain metabolism
Full Information
NCT ID
NCT01896167
First Posted
June 21, 2013
Last Updated
February 11, 2015
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT01896167
Brief Title
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Official Title
Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Aura
Keywords
Headache, Migraine, Aura, Cerebral hemodynamics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia
Arm Type
Active Comparator
Arm Description
Inhalation of air with 8-12% oxygen content
Arm Title
Atmospheric air
Arm Type
Placebo Comparator
Arm Description
Inhalation of atmospheric air, with oxygen content at 21%
Intervention Type
Other
Intervention Name(s)
Hypoxia
Intervention Description
Inhalation of hypoxic air (8-12% oxygen content)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inhalation of atmospheric air
Primary Outcome Measure Information:
Title
Headache and aura
Description
Comparison between hypoxia and placebo (atmospheric air)
Time Frame
24 h
Secondary Outcome Measure Information:
Title
artery circumference
Description
Hypoxia induced changes in intra- and extracranial circumference
Time Frame
Baseline, 120 and 200 min
Title
Cerebral blood flow
Description
Hypoxia induced changes in cerebral blood flow
Time Frame
Baseline, 120 and 200 min
Title
BOLD response in visual cortex
Description
Hypoxia induced changes in BOLD response
Time Frame
Baseline, 170 min and 220 min
Title
Brain metabolism
Description
Hypoxia induced changes in brain metabolism
Time Frame
Baseline, 180 min and 230 min post hypoxia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Arngrim, MD
Organizational Affiliation
Department of Neurology, Glostrup Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanna Arngrim
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
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Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
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