Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01741246
First received: November 26, 2012
Last updated: June 26, 2015
Last verified: June 2015
  Purpose

Investigators hypothesize that chronic primary headaches are accompanied by a discrete pattern of brain metabolism and activity involving brain structures related to the development of acute exacerbations as well as pain modulation. Such structures include the brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain imaging.


Condition
Migraine
Chronic Migraine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pattern of brain metabolism using positron emission tomography(PET). [ Time Frame: Estimated to be approximately three years post baseline ] [ Designated as safety issue: No ]
    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging to determine the pattern of brain metabolism.

  • Changes of resting state brain networks using magnetic resonance imaging (MRI) [ Time Frame: Estimated to be approximately three years post baseline ] [ Designated as safety issue: No ]
    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging (MRI) To determine any changes of resting state brain networks


Enrollment: 78
Study Start Date: September 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Headache-free subjects.
Episodic migraine
Patients with less that 15 headache days per month that fulfill International Classification of Headache Disorders 2R (ICHD-2nd edition Revised)- criteria for Episodic Migraine.
Chronic migraine
Patients that fulfill International Classification of Headache Disorders (ICHD)-2R criteria for chronic migraine (more than 15 days per month).

Detailed Description:

Specific aims of the study include:

  1. To determine the pattern of brain metabolism using positron emission tomography (PET) found in chronic migraine, episodic migraine and control patients.
  2. To determine changes of resting state brain networks using magnetic resonance imaging (MRI) between patients with chronic or episodic headache and healthy volunteers.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with episodic migraine, chronic migraine and control patients. Definitions are taken for the International Classification of Headache Disorders-2nd Edition (see references).

Criteria

Inclusion Criteria:

  • Patients aged 18-65

    • No medical contraindication.

Chronic headache group:

  • Patients with chronic primary headaches who are experiencing phases with background pain as well as habitual pain exacerbations.
  • Able to provide informed consent.
  • Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Control group and Episodic migraine group:

  • Patients with episodic migraine
  • Able to provide informed consent.
  • Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Exclusion Criteria:

  • Taking a migraine preventive currently or in the last fifteen days.
  • Known claustrophobia
  • Patient is pregnant, planning to be pregnant, or becomes pregnant.
  • Patients with metal implants.
  • Patients who have had a study involving radiation within the one year prior to enrolling in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741246

Locations
United States, California
UCSF
San Francisco, California, United States, 94115 & 94158
Sponsors and Collaborators
University of California, San Francisco
Allergan
Investigators
Principal Investigator: Amy Tso, MD University of California, San Francisco
Principal Investigator: Peter Goadsby, MD PhD University of California, San Francisco
Principal Investigator: Amy Gelfand, MD University of California, San Francisco
  More Information

Publications:
Talairach J, Tournoux P. Coplanar Stereotaxic Atlas of the Human Brain. New York: Thieme; 1988.
Valk PE, Delbeke D, Bailey DL, D.W. T, Maisey MN. Positron Emission Tomography: Springer; 2006.
Sprenger T, Seifert CL, Valet M, Staehle KS, Tölle TR, Foerschler A, Zimmer C, Goadsby PJ. Abnormal Interictal Resting State Activity in Episodic Migraine. Presented at the 62nd Annual Meeting of the American Academy of Neurology 2010, Toronto.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01741246     History of Changes
Other Study ID Numbers: 1107004
Study First Received: November 26, 2012
Last Updated: June 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Episodic migraine
Chronic migraine
Magnetic resonance imaging
Positron emission tomography

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2015