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History of Changes for Study: NCT02446262
Neural and Psychological Mechanisms of Pain Perception
Latest version (submitted August 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 15, 2015 None (earliest Version on record)
2 June 6, 2015 Study Description and Study Status
3 February 19, 2016 Study Status
4 August 2, 2016 Contacts/Locations and Study Status
5 August 10, 2016 Study Status
6 August 31, 2016 References and Study Status
7 December 17, 2016 Contacts/Locations and Study Status
8 December 20, 2016 Study Status
9 January 19, 2017 Study Status
10 January 20, 2017 Study Status
11 January 24, 2017 Study Status
12 January 31, 2017 Study Status
13 March 10, 2017 Study Status
14 April 21, 2017 Study Design and Study Status
15 April 28, 2017 Study Design, Study Description and Study Status
16 May 9, 2017 Study Status
17 June 6, 2017 Study Status
18 June 27, 2017 Study Status
19 June 30, 2017 Study Status
20 July 18, 2017 Study Status
21 October 11, 2017 Study Status
22 October 18, 2017 Study Status
23 November 7, 2017 Study Status
24 December 12, 2017 Eligibility and Study Status
25 December 14, 2017 Study Status
26 January 25, 2018 Study Status
27 February 3, 2018 Study Status
28 March 20, 2018 Study Status
29 March 27, 2018 Contacts/Locations and Study Status
30 May 9, 2018 Eligibility, Study Design and Study Status
31 May 22, 2018 Study Status
32 August 8, 2018 Oversight and Study Status
33 October 6, 2018 Study Status
34 October 27, 2018 Study Status
35 December 15, 2018 Study Status
36 January 30, 2019 Study Status
37 February 8, 2019 Study Status
38 August 7, 2019 Study Status
39 December 4, 2019 Study Design, Outcome Measures, Study Status, Arms and Interventions and Conditions
40 December 5, 2019 Outcome Measures and Study Status
41 December 19, 2019 Study Status
42 December 28, 2019 Oversight and Study Status
43 January 4, 2020 Study Status
44 February 4, 2020 Study Status
45 April 25, 2020 Eligibility and Study Status
46 April 28, 2020 Study Status
47 December 1, 2020 Study Status
48 December 16, 2020 Study Status
49 December 17, 2020 Study Status
50 March 17, 2021 Study Status
51 May 1, 2021 Study Status
52 July 24, 2021 Outcome Measures and Study Status
53 July 27, 2021 Study Status
54 September 15, 2021 Arms and Interventions, Study Design, Study Description and Study Status
55 September 17, 2021 Study Status
56 September 25, 2021 Arms and Interventions and Study Status
57 September 28, 2021 Study Status
58 October 1, 2021 Study Status
59 March 15, 2022 IPDSharing and Study Status
60 May 27, 2022 Study Status
61 June 3, 2022 Study Status and Study Description
62 July 6, 2022 Study Status
63 July 20, 2022 Eligibility and Study Status
64 July 21, 2022 Study Status
65 August 5, 2022 Study Status
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Study NCT02446262
Submitted Date:  May 15, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 150132
Brief Title: Neural and Psychological Mechanisms of Pain Perception
Official Title: Neural and Psychological Mechanisms of Pain Perception
Secondary IDs: 15-AT-0132
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: May 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: May 14, 2015
First Submitted that
Met QC Criteria:
May 15, 2015
First Posted: May 18, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 15, 2015
Last Update Posted: May 18, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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 2 clinic visits that last 1 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.
Detailed Description:

Objective:

Pain is one of the most important signals for an organism s survival. The pathways that transfer noxious input from the periphery to the central nervous system are highly conserved across human and animal models. In humans, the ultimate experience of pain is also highly influenced by psychological factors. For example, the placebo effect leads to robust pain relief and can influence responses to noxious stimuli in the human brain. However, the psychological and neurobiological mechanisms by which psychological factors influence pain remain largely unknown.

Pain can be modulated by explicit beliefs about treatments, prior experience and learning, interpersonal processes that support the patient-provider relationship, and contextual factors related to the treatment environment. In the proposed series of experiments, we will systematically investigate the neural and psychological mechanisms that mediate the effects of these factors on acute pain. We will focus on expectations, attention, emotion, conditioning/associative learning, and social factors. These experiments will principally use functional magnetic resonance imaging (fMRI) and psychophysiological measurements, as well as behavioral assays and self-reports. We will examine the effects of different types of pain-related expectations on decisions about pain as well as responses in the brain and periphery. We will also compare acute pain with other hedonic and perceptual processes. This will allow us to distinguish processes that are unique to pain perception from those that are not specific to pain, such as processes involved in perception and decision-making across domains.

Together, the proposed series of experiments aim to elucidate the psychological, neurobiological, and physiological mechanisms that modulate pain. This, in turn, can identify targets for pain treatment and inform mechanistic studies of altered pain processing in clinical populations.

Study Population:

We plan to recruit 260 healthy volunteers between age 18 and 50.

Design:

The aim of the proposed series of experiments is to understand how expectations, attention, and emotion influence acute pain. We will manipulate expectations about noxious stimuli using associative learning and verbal instructions, in both within-subjects and between-groups designs. We will measure decisions about pain experience (self-report) as well as neural and physiological responses to noxious stimuli that cause pain. We will combine computational modeling with advanced neuroimaging analyses to isolate the neural and psychological mechanisms that mediate the effects of expectations, attention, and emotion on subjective pain. To determine the specificity of these mechanisms, we will compare acute pain modalities (e.g., thermal pain versus shock-induced pain), and we will contrast pain with other hedonic and perceptual domains (e.g., taste).

Outcome measures:

Dependent variables for all experiments will include decisions about pain and/or other percepts (e.g., sweetness of a taste) measured with visual analogue scales, reaction time, physiological responses (e.g., skin conductance, pupil dilation), and/or BOLD activation in regions of interest. We are specifically interested in processes within the network of regions known to be involved in pain processing (pain-processing network, PPN), as well as responses in the prefrontal cortex (PFC), ventral striatum (VS), and amygdala. We hypothesize that nociceptive stimuli and pain ratings will be associated with unique patterns of activation within the PPN, whereas responses in regions associated with value, executive function, and decision-making will be common across outcomes.

Open or close this module Conditions
Conditions: Affective Neuroscience
Pain
Visual Analogue Pain Scale
Placebo
Functional Magnetic Resonance Imaging (fMRI)
Keywords: Pain
Visual Analogue Pain Scale
Placebo
Affective Neuroscience
Functional Magnetic Resonance Imaging (fMRI)
Open or close this module Study Design
Study Type: Observational
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 260 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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.
  • Used recreational drugs within the past month.
  • Is pregnant.
  • NCCIH employees.
  • Participation in an NIH study of analgesia, as gleaned from CRIS.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Troy C Dildine
Telephone: (301) 435-4845
Email: troy.dildine@nih.gov
Central Contact Backup: Lauren Y Atlas, Ph.D.
Telephone: (301) 827-0214
Email: lauren.atlas@nih.gov
Study Officials: Lauren Y Atlas, Ph.D.
Principal Investigator
National Center for Complementary and Integrative Health (NCCIH)
Locations: United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 Ext. TTY8664111010 prpl@mail.cc.nih.gov
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: NIH Clinical Center Detailed Web Page
Available IPD/Information:

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