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

June 26, 2015 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115 & 94158
        • UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of brain metabolism using positron emission tomography(PET).
Time Frame: Estimated to be approximately three years post baseline
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging to determine the pattern of brain metabolism.
Estimated to be approximately three years post baseline
Changes of resting state brain networks using magnetic resonance imaging (MRI)
Time Frame: Estimated to be approximately three years post baseline
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging (MRI) To determine any changes of resting state brain networks
Estimated to be approximately three years post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1107004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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