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Completed

NCT Number: NCT01777087

Functional Brain Imaging of Pain Phenotype and Genotype

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gauze soaked with capsaicin

Other

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.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Brain Imaging of Pain Phenotype and Genotype With Novel Scanning Techniques

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2013
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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