Clinical trial NCT00868556: fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
Official title: fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Episodic Migraine
Chronic Daily Migraine
Keywords: fMRI scans
episodic migraine sufferers
chronic migraine sufferers
non migraine sufferers (controls)
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-03-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 11 episodic migraine sufferers, 11 chronic migraine sufferers, 11 non-migraine sufferers

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.

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 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

Primary outcomes:
measure: assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls
timeFrame: within a month after consent is obtained
Secondary outcomes:
measure: correlate outcomes with headache surrogates (frequency, time since onset and age)
timeFrame: within one month after enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stewart J Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolff HG. Headache and Other Head Pain, New York: Oxford Univ Press; 1963
citation: 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.
citation: 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.
citation: 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.
citation: 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.