Functional Brain Imaging of Pain Phenotype and Genotype

Pain Clinical Trial

Official title:

Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777087
• Other study ID #: PRO12050474
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has two purposes: first, to locate and identify the "brain activation" (the areas of the brain) which respond to pain; and second, to look at how brain activation is influenced by a person's genetics (the traits they inherited from their parents). A Magnetic Resonance Imaging (MRI) scanner will be used to gather pictures of the brain (similar to an x-ray, but based on different scientific principles) that will be used to determine which areas are active. The hypothesis is that the variation in brain activity between people can be partially explained by genetic differences. This study consists of an two pain tasks applied during a one time visit to the MRI suite. There are no followup visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18 to 50

• Right-handed

• Male or female

• Healthy individuals not taking any medication.

Exclusion Criteria:

• Pregnancy

• Diagnosed with any treated or untreated medical or neurological conditions

• Using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. Oral contraceptives are permitted

• Using any over-the-counter medications including aspirin, Tylenol, or herbal supplements

• Using any illicit substances

• Contraindications to magnetic resonance imaging.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• gauze soaked with capsaicin
This is a basic science study determining the brain activation that results from painful stimulation. All subjects will have the same painful stimulations and brain images collected.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

Balaban CD, McBurney DH, Affeltranger MA. Three distinct categories of time course of pain produced by oral capsaicin. J Pain. 2005 May;6(5):315-22. — View Citation

Campbell CM, Edwards RR, Carmona C, Uhart M, Wand G, Carteret A, Kim YK, Frost J, Campbell JN. Polymorphisms in the GTP cyclohydrolase gene (GCH1) are associated with ratings of capsaicin pain. Pain. 2009 Jan;141(1-2):114-8. doi: 10.1016/j.pain.2008.10.023. Epub 2008 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Areas of brain activity from a transcutaneous painful stimulation	A nerve stimulator will be turned on at the level that causes you to report 7/10 pain for 30 seconds, followed by a 30 second period of rest. This will be repeated four times. The areas of brain activity are determined at the end of the 1 hour scanning session by analyzing the brain images. There are no additional followup or long term outcomes.	At the conclusion of the 1 hour scanning session; Visit one
Primary	Areas of brain activity from a 45 minutes Capsaicin cream application	The painful stimulation will now be caused by placing a piece of gauze soaked with capsaicin, the active ingredients in chili peppers, on the subject's right arm. The areas of brain activity are determined at the end of the 1 hour scanning session by analyzing the brain images. There are no additional followup or long term outcomes.	At the conclusion of the 1 hour scanning session; Visit 1
Secondary	Pain phenotyping	Subjects will report their pain at least every 3 minutes during the cream application. The subject's pain phenotype will be determined from this response.	After the 45 minute Capsaicin cream application; Visit 1