Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Structural and Molecular Neuroplasticity in Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03004313
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandre DaSilva, DDS, MS, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Migraine Procedure: Pet Scan Procedure: MRI scan Procedure: Quantitative Sensory Testing (QST) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Structural and Molecular Neuroplasticity in Migraine
Study Start Date : January 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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)
 Procedure: Pet Scan
Subjects will undergo Pet Scanning for 90 minutes

Procedure: MRI scan
Procedure: Quantitative Sensory Testing (QST)
Active Comparator: 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
 Procedure: Pet Scan
Subjects will undergo Pet Scanning for 90 minutes

Procedure: MRI scan
Procedure: Quantitative Sensory Testing (QST)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential [ Time Frame: 90 min PET scan ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004313


Locations
Layout table for location information
United States, Michigan
University of Michigan - Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Layout table for investigator information
Principal Investigator: Alexandre DaSilva, DDS, MS University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Alexandre DaSilva, DDS, MS, Principal Investigator, Director of Headache and Orofacial Pain Effort, University of Michigan
ClinicalTrials.gov Identifier: NCT03004313    
Other Study ID Numbers: HUM00027383
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Keywords provided by Alexandre DaSilva, DDS, MS, University of Michigan:
migraine
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases