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Trial record 2 of 32 for:    atlas pain

Neural and Psychological Mechanisms of Pain Perception

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ClinicalTrials.gov Identifier: NCT02446262
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )

Brief Summary:

Background:

- Painful stimuli cause changes in a network of brain regions called the Pain Matrix. But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision.

Objectives:

- To better understand how pain and emotions are processed and influenced by psychological factors.

Eligibility:

- Healthy volunteers ages 18 50.

Design:

  • This study requires 1 to 2 clinic visits that last 1 to 3 hours.
  • Participants will be screened with medical history and physical exam.
  • Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs.
  • Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored.
  • Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI.
  • Participants will fill out questionnaires.
  • The study will last 3 years.

Condition or disease
Affective Neuroscience Pain Visual Analogue Pain Scale Placebo Functional Magnetic Resonance Imaging (fMRI)

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neural and Psychological Mechanisms of Pain Perception
Study Start Date : May 14, 2015
Estimated Primary Completion Date : December 3, 2018
Estimated Study Completion Date : December 3, 2018



Primary Outcome Measures :
  1. Pain perception (pain ratings) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. State-trait anxiety index, Fear of Pain questionnaire, Intolerance of Uncertainty questionnaire, McGill Pain Questionnaire) [ Time Frame: 2 years ]


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:
  • Healthy
  • Between 18 and 50 years old
  • Fluent in English
  • Able to provide written informed consent.

EXCLUSION CRITERIA:

  • Unable to comply with study procedures or follow-up visits.
  • Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, neurological or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis) or a chronic systemic disease (e.g., diabetes).
  • Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder).
  • Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
  • Has a dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous 4 weeks that might influence cutaneous sensibility.
  • Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-nflammatories, salicylates, and acetaminophen, taken on an "as needed" basis is acceptable as long as the last dose taken was within 5 half-lives of testing.
  • Used recreational drugs within the past month.
  • Is pregnant.
  • NCCIH employees.

EXCLUSION CRITERIA (fMRI sub-studies):

  • Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure or pain stimulation will be excluded from the MRI portion of the protocol, but may participate in the non-fMRI sessions (with the exception of pregnant women). Such conditions include:

    • Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
    • Those with an abnormality on a structural MRI.
    • Those with an implanted cardiac pacemaker or auto-defibrillator.
    • Those with an insulin pump.
    • Those with an irremovable body piercing.
    • Pregnant women (based on urine test completed within 24 hours prior to scan).
  • Individuals who are left-handed (based on self-report or score on handedness questionnaire) will be excluded from fMRI substudies.

EXCLUSION CRITERIA (placebo analgesia sub-studies):

-Participation in an NIH study of analgesia, as gleaned from CRIS


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): NCT02446262


Contacts
Contact: Adebisi O Ayodele, C.R.N.P. (301) 827-0415 bisi.ayodele@nih.gov
Contact: Lauren Y Atlas, Ph.D. (301) 827-0214 lauren.atlas@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Lauren Y Atlas, Ph.D. National Center for Complementary and Integrative Health (NCCIH)

Additional Information:
Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT02446262     History of Changes
Other Study ID Numbers: 150132
15-AT-0132
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: May 8, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) ):
Pain
Visual Analogue Pain Scale
Placebo
Affective Neuroscience
Functional Magnetic Resonance Imaging (fMRI)