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

• ClinicalTrials.gov Identifier: NCT00868556
• Recruitment Status: Completed
• First Posted: March 25, 2009
• Last Update Posted: January 5, 2010
• Sponsor: The Cleveland Clinic
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by: The Cleveland Clinic

Study Description

Brief Summary:

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 or disease
Episodic Migraine; Chronic Daily Migraine

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 33 participants
• 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?
• Study Start Date: January 2009
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: August 2009

Groups and Cohorts

Group/Cohort
1 episodic migraine sufferers
2 chronic migraine sufferers
3 non migraine sufferers (controls)

Outcome Measures

Primary Outcome Measures :

1. assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls [ Time Frame: within a month after consent is obtained ]

Secondary Outcome Measures :

1. correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Stewart J Tepper, MD; The Cleveland Clinic

More Information

Publications:

Wolff HG. Headache and Other Head Pain, New York: Oxford Univ Press; 1963

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. doi: 10.1046/j.1526-4610.2001.041007629.x.

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. doi: 10.1111/j.1526-4610.1994.hed3401001.x.

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. doi: 10.1212/wnl.47.4.871.

Bigal ME, Tepper SJ, Sheftell FD, Rapoport AM, Lipton RB. Field testing alternative criteria for chronic migraine. Cephalalgia. 2006 Apr;26(4):477-82. doi: 10.1111/j.1468-2982.2006.01128.x.

• Responsible Party: Stewart Tepper MD, PI, Cleveland Clinic Foundation
• ClinicalTrials.gov Identifier: NCT00868556
• Other Study ID Numbers: V81708; Merck Grant IISP 36047
• First Posted: March 25, 2009
• Last Update Posted: January 5, 2010
• Last Verified: March 2009

Keywords provided by The Cleveland Clinic:

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

Additional relevant MeSH terms:

Siderosis; Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases