Functional MRI (fMRI) in CGRP Induced Migraine - Full Text View

Sponsored by:	Danish Headache Center
Information provided by:	Danish Headache Center
ClinicalTrials.gov Identifier:	NCT00363532

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:	Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

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

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

Keywords provided by Danish Headache Center:

migraine with out aura

Study placed in the following topic categories:

Calcitonin
Vasodilator Agents
Central Nervous System Diseases
Headache Disorders, Primary
Bone Density Conservation Agents
Cardiovascular Agents
Brain Diseases

Salmon calcitonin
Headache Disorders
Calcitonin Gene-Related Peptide
Migraine Disorders
Headache
Migraine without Aura

Additional relevant MeSH terms:

Calcitonin
Vasodilator Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Bone Density Conservation Agents
Headache Disorders, Primary
Cardiovascular Agents

Brain Diseases
Pharmacologic Actions
Headache Disorders
Calcitonin Gene-Related Peptide
Migraine Disorders
Therapeutic Uses
Migraine without Aura

ClinicalTrials.gov processed this record on September 02, 2009