NCT01777087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

3.2 years

First QC Date

January 10, 2013

Last Update Submit

May 1, 2018

Conditions

Pain

Keywords

PainFunctional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Areas of brain activity from a transcutaneous painful stimulation

    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.

    At the conclusion of the 1 hour scanning session; Visit one

  • Areas of brain activity from a 45 minutes Capsaicin cream application

    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.

    At the conclusion of the 1 hour scanning session; Visit 1

Secondary Outcomes (1)

  • Pain phenotyping

    After the 45 minute Capsaicin cream application; Visit 1

Study Arms (1)

Healthy normal volunteers

EXPERIMENTAL

Healthy normal volunteers

Other: gauze soaked with capsaicin

Interventions

gauze soaked with capsaicinOTHER

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.

Healthy normal volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 50
  • Right-handed
  • Male or female
  • Healthy individuals not taking any medication.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Balaban CD, McBurney DH, Affeltranger MA. Three distinct categories of time course of pain produced by oral capsaicin. J Pain. 2005 May;6(5):315-22. doi: 10.1016/j.jpain.2005.01.346.

    PMID: 15890633BACKGROUND

  • Campbell CM, Edwards RR, Carmona C, Uhart M, Wand G, Carteret A, Kim YK, Frost J, Campbell JN. Polymorphisms in the GTP cyclohydrolase gene (GCH1) are associated with ratings of capsaicin pain. Pain. 2009 Jan;141(1-2):114-8. doi: 10.1016/j.pain.2008.10.023. Epub 2008 Dec 9.

    PMID: 19081190BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • James W Ibinson, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 28, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

US(1)