Functional Brain Imaging of Pain Phenotype and Genotype

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: gauze soaked with capsaicin

• Registration Number: NCT01777087
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-28
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy normal volunteers	gauze soaked with capsaicin	Healthy normal volunteers

Primary Outcome Measures

Name	Time	Method
Areas of brain activity from a transcutaneous painful stimulation	At the conclusion of the 1 hour scanning session; Visit one	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.
Areas of brain activity from a 45 minutes Capsaicin cream application	At the conclusion of the 1 hour scanning session; Visit 1	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.

Secondary Outcome Measures

Name	Time	Method
Pain phenotyping	After the 45 minute Capsaicin cream application; Visit 1	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States