Structural and Molecular Neuroplasticity in Migraine

Migraine Clinical Trial

Official title:

Structural and Molecular Neuroplasticity in Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004313
• Other study ID #: HUM00027383
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: November 21, 2017
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• Pet Scan
Subjects will undergo Pet Scanning for 90 minutes
• MRI scan

• Quantitative Sensory Testing (QST)

Locations

Country	Name	City	State
United States	University of Michigan - Michigan Center for Oral Health Research	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential		90 min PET scan