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

NCT ID: NCT00868556

Last Updated: 2010-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Episodic Migraine Chronic Daily Migraine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1 episodic migraine sufferers

No interventions assigned to this group

2 chronic migraine sufferers

No interventions assigned to this group

3 non migraine sufferers (controls)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cleveland Clinic Foundation

Principal Investigators

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Stewart J Tepper, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11554950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8132434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8857711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16556250 (View on PubMed)

Other Identifiers

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Merck Grant IISP 36047

Identifier Type: -

Identifier Source: secondary_id

V81708

Identifier Type: -

Identifier Source: org_study_id

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