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Functional Brain Imaging of Pain Phenotype and Genotype

This study is currently recruiting participants.
Verified January 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01777087
First received: January 10, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Pain
 Other: gauze soaked with capsaicin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
Drug Information available for: Capsaicin
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Areas of brain activity from a transcutaneous painful stimulation [ Time Frame: At the conclusion of the 1 hour scanning session; Visit one ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the conclusion of the 1 hour scanning session; Visit 1 ] [ Designated as safety issue: No ]
    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:
  • Pain phenotyping [ Time Frame: After the 45 minute Capsaicin cream application; Visit 1 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777087

Contacts
Contact: James W Ibinson, MD, PhD 412-383-5911 ibinsonjw@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: James W Ibinson     412-383-5911     ibinsonjw@upmc.edu    
Principal Investigator: James W Ibinson, MD, PhD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: James W Ibinson, MD, PhD University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01777087     History of Changes
Other Study ID Numbers: PRO12050474
Study First Received: January 10, 2013
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pain
Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013