Structural and Molecular Neuroplasticity in Migraine

November 21, 2017 updated by: Alexandre DaSilva, DDS, MS, University of Michigan
The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan - Michigan Center for Oral Health Research

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18-45 years of age
  • Between 1-14 migraine attacks per month or healthy

Exclusion Criteria:

  • Cannot be taking daily migraine medication
  • Healthy subjects cannot be taking hormonal birth control pills or other medication
  • Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Migraine

20 subjects experiencing 1-14 migraines per month will undergo the following:

  • Blood and urine samples will be collected
  • Complete a series of questionnaires; some of which will be completed daily
  • Quantitative Sensory Test (QST)will be performed
  • Magnetic Resonance Imaging (MRI)
  • PET imaging (during and outside of a migraine attack)
Procedure: Pet Scan
Subjects will undergo Pet Scanning for 90 minutes
Procedure: MRI scan
Procedure: Quantitative Sensory Testing (QST)
Active Comparator: Healthy

20 healthy subjects will undergo the following:

  • Blood and urine samples will be collected
  • Complete a series of questionnaires; some of which will be completed daily
  • Quantitative Sensory Test (QST)will be performed
  • Magnetic Resonance Imaging (MRI)
  • PET imaging
Procedure: Pet Scan
Subjects will undergo Pet Scanning for 90 minutes
Procedure: MRI scan
Procedure: Quantitative Sensory Testing (QST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.
Time Frame: 90 min PET scan
90 min PET scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
Time Frame: 90 min PET scan
90 min PET scan

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Alexandre DaSilva, DDS, MS, University of Michigan

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

January 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00027383

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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