NCT03004313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

August 30, 2011

Last Update Submit

November 21, 2017

Conditions

Migraine

Keywords

migraine

Outcome Measures

Primary Outcomes (1)

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

    90 min PET scan

Secondary Outcomes (1)

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

    90 min PET scan

Study Arms (2)

Migraine

EXPERIMENTAL

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 ScanProcedure: MRI scanProcedure: Quantitative Sensory Testing (QST)

Healthy

ACTIVE COMPARATOR

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 ScanProcedure: MRI scanProcedure: Quantitative Sensory Testing (QST)

Interventions

Pet ScanPROCEDURE

Subjects will undergo Pet Scanning for 90 minutes

HealthyMigraine
MRI scanPROCEDURE
HealthyMigraine
Quantitative Sensory Testing (QST)PROCEDURE
HealthyMigraine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan - Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

  • 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.

    PMID: 31279240DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Alexandre DaSilva, DDS, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Director of Headache and Orofacial Pain Effort

Study Record Dates

First Submitted

August 30, 2011

First Posted

December 28, 2016

Study Start

January 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)