RECRUITING

Neural and Psychological Mechanisms of Pain Perception

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neural and Psychological Mechanisms of Pain Perception

Quick Facts

Study Start:2015-06-11
Study Completion:2026-02-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02446262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy
  2. * Between 18 and 50 years old
  3. * Fluent in English
  4. * Able to provide written informed consent.
  5. * Unable to comply with study procedures or follow-up visits.
  6. * 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, or neurological conditions, including stroke, blindness, deafness, a history of brain damage, or a chronic systemic disease (e.g., diabetes).
  7. * Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.
  8. * Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder).
  9. * Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
  10. * Has a dermatological condition affecting the testing region such as scars, burns, or recent tattoos that might influence cutaneous sensibility.
  11. * 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.
  12. * Is pregnant.
  13. * NIH staff member who is a subordinate/relative/co-worker of any investigator on the protocol.
  14. * 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:
  15. * Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
  16. * Those with an abnormality on a structural MRI.
  17. * Those with an implanted cardiac pacemaker or auto-defibrillator.
  18. * Those with an insulin pump.
  19. * Those with an irremovable body piercing.
  20. * Pregnant women (based on urine test completed within 24 hours prior to scan).
  21. * Individuals who are left-handed (based on self-report or score on handedness questionnaire) will be excluded from fMRI substudies.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Adebisi O Ayodele, C.R.N.P.
CONTACT
(240) 593-4226
bisi.ayodele@nih.gov
Lauren Y Atlas, Ph.D.
CONTACT
(301) 827-0214
lauren.atlas@nih.gov

Principal Investigator

Lauren Y Atlas, Ph.D.
PRINCIPAL_INVESTIGATOR
National Center for Complementary and Integrative Health (NCCIH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Center for Complementary and Integrative Health (NCCIH)

  • Lauren Y Atlas, Ph.D., PRINCIPAL_INVESTIGATOR, National Center for Complementary and Integrative Health (NCCIH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06-11
Study Completion Date2026-02-20

Study Record Updates

Study Start Date2015-06-11
Study Completion Date2026-02-20

Terms related to this study

Keywords Provided by Researchers

  • Pain
  • Visual Analogue Pain Scale
  • Placebo
  • Affective Neuroscience
  • Functional Magnetic Resonance Imaging (fMRI)

Additional Relevant MeSH Terms

  • Pain
  • Normal Physiology
  • Healthy Volunteers