Structural and Molecular Neuroplasticity in Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Procedure: Pet Scan; Procedure: MRI scan; Procedure: Quantitative Sensory Testing (QST)

• Registration Number: NCT03004313
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-30
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine	Quantitative Sensory Testing (QST)	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)
Healthy	Pet Scan	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
Migraine	MRI scan	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)
Healthy	MRI scan	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
Healthy	Quantitative Sensory Testing (QST)	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
Migraine	Pet Scan	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential	90 min PET scan

Trial Locations

Locations (1)

University of Michigan - Michigan Center for Oral Health Research; 🇺🇸 Ann Arbor, Michigan, United States