fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease? - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	Merck
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00868556

Purpose

This is a 2 visit research study for patients with or without a diagnosis of migraine. Participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. The participants will have a functional MRI performed after completion of Visit 1. Study stipends will be given for each completed research visit.

The purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain MRI scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional MRI scans.

Condition
Episodic Migraine Chronic Daily Migraine

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Iron Migraine Nuclear Scans

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls [ Time Frame: within a month after consent is obtained ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	January 2009
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 episodic migraine sufferers
2 chronic migraine sufferers
3 non migraine sufferers (controls)

Detailed Description:

At Visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. Each of these enrolled subjects will have a PRIME MD assessment administered, and will complete the MIDAS and ASC-12 questionnaires.

At Visit 2 these same subjects will have an fMRI performed.

Subjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fMRI performed (have implanted metal devices, have severe claustrophobia).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

11 episodic migraine sufferers, 11 chronic migraine sufferers, 11 non-migraine sufferers

Criteria

Inclusion Criteria:

adult episodic, chronic or non-migraine sufferers able to consent

Exclusion Criteria:

contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868556

Locations

United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Merck

Investigators

Principal Investigator:

Stewart J Tepper, MD

The Cleveland Clinic

More Information

Publications:

Welch KM, Nagesh V, Aurora SK, Gelman N. Periaqueductal gray matter dysfunction in migraine: cause or the burden of illness? Headache. 2001 Jul-Aug;41(7):629-37.

Siberstein SD, Lipton RB, Solomon S, Mathew NT. Classification of daily and near-daily headaches: proposed revisions to the IHS criteria. Headache. 1994 Jan;34(1):1-7. Review.

Silberstein SD, Lipton RB, Sliwinski M. Classification of daily and near-daily headaches: field trial of revised IHS criteria. Neurology. 1996 Oct;47(4):871-5.

Bigal ME, Tepper SJ, Sheftell FD, Rapoport AM, Lipton RB. Field testing alternative criteria for chronic migraine. Cephalalgia. 2006 Apr;26(4):477-82.

Responsible Party:	Stewart Tepper MD, PI, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:	NCT00868556 History of Changes
Other Study ID Numbers:	V81708, Merck Grant IISP 36047
Study First Received:	March 24, 2009
Last Updated:	January 4, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

fMRI scans
episodic migraine sufferers
chronic migraine sufferers
non migraine sufferers (controls)

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012