ClinicalTrials.Veeva

Menu

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

D

Danish Headache Center

Status

Completed

Conditions

Migraine
Aura
Headache

Treatments

Other: Placebo
Other: Hypoxia

Study type

Interventional

Funder types

Other

Identifiers

NCT01896167
H-4-2012-182

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

34 participants in 2 patient groups, including a placebo group

Hypoxia
Active Comparator group
Description:
Inhalation of air with 8-12% oxygen content
Treatment:
Other: Hypoxia
Atmospheric air
Placebo Comparator group
Description:
Inhalation of atmospheric air, with oxygen content at 21%
Treatment:
Other: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems