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Structural and Molecular Neuroplasticity in Migraine

NCT ID: NCT03004313

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Migraine

Keywords

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migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Pet Scan

Intervention Type PROCEDURE

Subjects will undergo Pet Scanning for 90 minutes

MRI scan

Intervention Type PROCEDURE

Quantitative Sensory Testing (QST)

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Pet Scan

Intervention Type PROCEDURE

Subjects will undergo Pet Scanning for 90 minutes

MRI scan

Intervention Type PROCEDURE

Quantitative Sensory Testing (QST)

Intervention Type PROCEDURE

Interventions

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Pet Scan

Subjects will undergo Pet Scanning for 90 minutes

Intervention Type PROCEDURE

MRI scan

Intervention Type PROCEDURE

Quantitative Sensory Testing (QST)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Alexandre DaSilva, DDS, MS

Principal Investigator, Director of Headache and Orofacial Pain Effort

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre DaSilva, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan - Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31279240 (View on PubMed)

Other Identifiers

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HUM00027383

Identifier Type: -

Identifier Source: org_study_id