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Functional Brain Imaging of Pain Phenotype and Genotype

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ClinicalTrials.gov Identifier: NCT01777087
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jim Ibinson, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 10, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date May 2, 2018
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01777087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Brain Imaging of Pain Phenotype and Genotype
Official Title  ICMJE Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Healthy normal volunteers
Healthy normal volunteers
Intervention: Other: gauze soaked with capsaicin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)
30
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01777087
Other Study ID Numbers  ICMJE PRO12050474
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jim Ibinson, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James W Ibinson, MD, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP