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CompletedNCT00868556Updated Jan 5, 2010

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

An observational study in Episodic Migraine and Chronic Daily Migraine, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-05.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Episodic Migraine
  • Chronic Daily Migraine

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Keywords

  • fMRI scans
  • episodic migraine sufferers
  • chronic migraine sufferers
  • non migraine sufferers (controls)
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 33 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
  • pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
33 participants (actual)

Groups and cohorts

  • 1 episodic migraine sufferers
  • 2 chronic migraine sufferers
  • 3 non migraine sufferers (controls)
06

What researchers measure

Primary outcomes

  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 outcomes

  1. correlate outcomes with headache surrogates (frequency, time since onset and age)

    Time frame: within one month after enrollment

07

Study locations

1 site
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
08

References and documents

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. PubMed 11554950 ↗
  • 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. PubMed 8132434 ↗
  • 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. PubMed 8857711 ↗
  • 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. PubMed 16556250 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00868556
Lead sponsor
The Cleveland Clinic
First posted
Mar 25, 2009
Start date
Jan 2009
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Jan 5, 2010

Study contacts

Stewart J Tepper, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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