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Structural and Molecular Neuroplasticity in Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pet Scan
MRI scan
Quantitative Sensory Testing (QST)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Migraine focused on measuring migraine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan - Michigan Center for Oral Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Migraine

Healthy

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.

Secondary Outcome Measures

Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential

Full Information

First Posted
August 30, 2011
Last Updated
November 21, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03004313
Brief Title
Structural and Molecular Neuroplasticity in Migraine
Official Title
Structural and Molecular Neuroplasticity in Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Migraine
Arm Type
Experimental
Arm Description
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)
Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Pet Scan
Intervention Description
Subjects will undergo Pet Scanning for 90 minutes
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Intervention Type
Procedure
Intervention Name(s)
Quantitative Sensory Testing (QST)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
Time Frame
90 min PET scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre DaSilva, DDS, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan - Michigan Center for Oral Health Research
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31279240
Citation
Jassar H, Nascimento TD, Kaciroti N, DosSantos MF, Danciu T, Koeppe RA, Smith YR, Bigal ME, Porreca F, Casey KL, Zubieta JK, DaSilva AF. Impact of chronic migraine attacks and their severity on the endogenous mu-opioid neurotransmission in the limbic system. Neuroimage Clin. 2019;23:101905. doi: 10.1016/j.nicl.2019.101905. Epub 2019 Jun 18.
Results Reference
derived

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Structural and Molecular Neuroplasticity in Migraine

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