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

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NeuroTherapia, Inc.

Status

Completed

Conditions

Chronic Daily Migraine
Episodic Migraine

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00868556
Merck Grant IISP 36047
V81708

Details and patient eligibility

About

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.

Full 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).

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

33 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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