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Completed

NCT Number: NCT00363532

Functional MRI (fMRI) in CGRP Induced Migraine

In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata.

Then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail.

This study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center, Neurological Dep. Glostrup hospital

Glostrup Municipality, 2770, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients know with migraine without aura.
  • No less then 1 migraine attach pr month and no more then 6 attaches per month.
  • Weight 50-100 kg.
  • Women must be using secure birthcontrol.

Exclusion criteria

  • Tension type headache more then 1 day/month.
  • All other prim. og sec. headache types then migraine without aura.
  • Daily use of medication other then birthcontrol pills.
  • Pregnant and lactation women.
  • Headache on the trail day or 5 days previous to the trail day.
  • Contraindications to MRI-scans.
  • Hypertension or hypotension.
  • Known heart or lung condition.
  • Mental illness or substance abuse.
  • Other considerable conditions judged by the including doctor.

Treatment and study plan

infusion of calcitonin gene related peptide (CGRP)

Drug

Primary outcomes

  1. Changes in BOLD response before and after CGRP infusion.

  2. Changes in BOLD response before and after injection of sumatriptan.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2006
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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