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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00868556
First received: March 24, 2009
Last updated: January 4, 2010
Last verified: March 2009

March 24, 2009
January 4, 2010
January 2009
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00868556 on ClinicalTrials.gov Archive Site
correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Episodic Migraine
  • Chronic Daily Migraine
Not Provided
  • 1 episodic migraine sufferers
  • 2 chronic migraine sufferers
  • 3 non migraine sufferers (controls)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00868556
V81708, Merck Grant IISP 36047
No
Stewart Tepper MD, PI, Cleveland Clinic Foundation
The Cleveland Clinic
Merck Sharp & Dohme Corp.
Principal Investigator: Stewart J Tepper, MD The Cleveland Clinic
The Cleveland Clinic
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP