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Functional Brain Imaging of Pain Phenotype and Genotype

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777087
First Posted: January 28, 2013
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jim Ibinson, University of Pittsburgh
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques

Resource links provided by NLM:


Further study details as provided by Jim Ibinson, 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 ]
    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 ]
    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 ]
    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.


Enrollment: 15
Study Start Date: January 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777087


Locations
United States, Pennsylvania
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
  More Information

Publications:
Responsible Party: Jim Ibinson, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01777087     History of Changes
Other Study ID Numbers: PRO12050474
First Submitted: January 10, 2013
First Posted: January 28, 2013
Last Update Posted: June 26, 2017
Last Verified: June 2017

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

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