Functional Brain Imaging of Pain Phenotype and Genotype

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01777087
Collaborator
(none)
15
1
1
37.9
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: gauze soaked with capsaicin
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy normal volunteers

Healthy normal volunteers

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: James W Ibinson, MD, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jim Ibinson, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01777087
Other Study ID Numbers:
  • PRO12050474
First Posted:
Jan 28, 2013
Last Update Posted:
May 2, 2018
Last Verified:
May 1, 2018
Keywords provided by Jim Ibinson, MD, PhD, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2018