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Completed

NCT Number: NCT03004313

Structural and Molecular Neuroplasticity in Migraine

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET Scan

Procedure

Subjects will undergo Pet Scanning for 90 minutes

MRI scan

Procedure

quantitative sensory testing (QST)

Procedure

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.

    Time frame: 90 min PET scan

Secondary outcomes

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

    Time frame: 90 min PET scan

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2016
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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