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Neural and Psychological Mechanisms of Pain Perception

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02446262
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : April 29, 2020
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 Intervention/treatment Phase
Pain Normal Physiology Healthy Volunteers Behavioral: Instructions Behavioral: Attention Behavioral: Thermal Pain Behavioral: Placebo instructions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Neural and Psychological Mechanisms of Pain Perception
Actual Study Start Date : June 11, 2015
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : June 15, 2021

Arm Intervention/treatment
Substudy 1: Instructed subjects
Participants are instructed about outcomes
Behavioral: Instructions
In sub-study 1, half the participants are instructed about outcomes, half learn through experience.

Substudy 1: Uninstructed subjects
Participants learn through experience
Behavioral: Instructions
In sub-study 1, half the participants are instructed about outcomes, half learn through experience.

Substudy 2: heat group
Participants learn about heat outcomes through conditioning
Behavioral: Thermal Pain
In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.

Substudy 2: salt group
Participants learn about salt outcomes through conditioning
Behavioral: Thermal Pain
In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.

Substudy 2: sugar group
Participants learn about sugar outcomes through conditioning
Behavioral: Thermal Pain
In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.

No Intervention: Substudy 3: healthy volunteers
All participants experience all outcomes, within subjects designs
Substudy 4: healthy volunteers
Participants are instructed to attend toward or away from the stimulus
Behavioral: Attention
In sub-study 4, participants learn about outcomes and we manipulate attention toward or away from the pain.

Substudy 5: healthy volunteers
Participants experience both placebo and cue-based expectations within subjects
Behavioral: Attention
In sub-study 4, participants learn about outcomes and we manipulate attention toward or away from the pain.

Behavioral: Placebo instructions
In sub-study 5, we test whether placebo effects and expectancy cues modulate pain through similar mechanisms.




Primary Outcome Measures :
  1. Pain perception (pain ratings) [ Time Frame: During the study visit in response to painful stimuli. ]
    Substudies of pain collect pain ratings using a visual analogue scale, either verbally or via computer.

  2. BOLD response in brain regions of interest measured using fMRI [ Time Frame: During the study visit in response to painful and nonpainful stimuli. ]
    FMRI substudies proceed following behavioral substudies. We measure brain responses in anticipation and response to painful and nonpainful stimuli.

  3. Physiological responses (heart rate, skin conductance, respiration, pupil dilation, eye gaze position) [ Time Frame: During the study visit in response to painful and nonpainful stimuli. ]
    In behavioral and fMRI experiments, we measure autonomic responses in anticipation and response to painful and non-painful stimuli using non-invasive measures.


Secondary Outcome Measures :
  1. Questionnaire measures (e.g. State-trait anxiety index, Fear of Pain questionnaire, Intolerance of Uncertainty questionnaire, McGill Pain Questionnaire) [ Time Frame: Trait measures are collected during initial screening visit ; State measures are collected on every visit ]
    Personality measures that have been linked with painand emotion will be tested as moderators of effects on the above outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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-inflammatories, 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.
  • 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
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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
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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
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Principal Investigator: Lauren Y Atlas, Ph.D. National Center for Complementary and Integrative Health (NCCIH)

Additional Information:
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Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT02446262    
Other Study ID Numbers: 150132
15-AT-0132
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 24, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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)