Functional MRI (fMRI) in CGRP Induced Migraine

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00363532
First received: August 11, 2006
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Migraine Without Aura
Drug: infusion of calcitonin gene related peptide (CGRP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Changes in BOLD response before and after CGRP infusion.
  • Changes in BOLD response before and after injection of sumatriptan.

Estimated Enrollment: 12
Study Start Date: September 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00363532

Locations
Denmark
Danish Headache Center, Neurological Dep. Glostrup hospital
Glostrup, Denmark, 2770
Sponsors and Collaborators
Danish Headache Center
Investigators
Study Chair: Messoud Ashina, MD,PH.d Danish Headache Center
  More Information

No publications provided

Responsible Party: Mohammad Sohail Asghar, MD, Neurological Dep. University of Copenhagen, Denmark, Glostrup Hospital.
ClinicalTrials.gov Identifier: NCT00363532     History of Changes
Other Study ID Numbers: KA-20060083
Study First Received: August 11, 2006
Last Updated: January 27, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Danish Headache Center:
migraine with out aura

Additional relevant MeSH terms:
Migraine Disorders
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014