RECRUITING

Neural Correlates of Hypoalgesia Driven by Observation

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

Placebo effects held an ambivalent place in health care for at least two centuries. On the one hand, placebos are traditionally used as controls in clinical trials to correct for biases and the placebo response is viewed as an effect to be factored out in order to isolate and accurately measure the effects of the treatment. On the other hand, there is scientific evidence that placebo effects represent fascinating psychoneurobiological events involving the contribution of distinct central nervous as well as peripheral physiological mechanisms that influence pain perception and clinical pain symptoms and substantially modulate the response to pain therapeutics. Therefore, placebo effects have shifted from being a challenge for clinical trials to a resource to trigger the reduction of pain based on endogenous mechanisms that can be activated in the brain to promote hypolagesia, self-healing, and well-being. This is relevant in acute pain settings given that chronic opioid users die within approximately 2.5 years of being prescribed their first opioid medication to treat acute pain. The overall hypothesis is that observational learning influences neural pain modulation and cognition systems, including processes associated with mentalizing (the ability to cognitively understand mental states of others), empathy (the ability to share an emotional experience), and expectancy (the anticipation of a benefit). The objective is to determine the brain mechanisms of observationally-induced analgesia using brain mapping approaches that target changes in blood oxygenation and oscillatory activity in the brain, thus enabling investigators to draw inferences about the localization and extent of neurobiological activation underlying hypoalgesia driven by observation. Therefore, the investigators designed innovative experiments using pharmacological fMRI, EEG, and combined EEG-fMRI measurements.

Official Title

Neural Correlates of Hypoalgesia Driven by Observation

Quick Facts

Study Start:2021-11-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03897998

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 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age (18-55 years old)
  2. * English speaker (written and spoken)
  1. * Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, degenerative neuromuscular disease, or history of cancer within past 3 years
  2. * Any history of chronic pain disorder or currently in pain
  3. * Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and /or psychiatric condition leading to treatment and/or hospitalization within the last 3 years.
  4. * Personal history of mania, schizophrenia, or other psychoses
  5. * Nasal Polyps
  6. * Chronic intranasal drug use ( e.g., intranasal decongestants; antihistamines)
  7. * Lifetime alcohol/drug dependence, or alcohol/drug abuse in past 3 months
  8. * Use of antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and/or narcotics during the past 3 months
  9. * Pregnancy or breast feeding
  10. * Color-blindness
  11. * Impaired, uncorrected hearing
  12. * Left handed
  13. * Allergies or sensitivities to creams, lotions, or food coloring
  14. * Any non-organic implant or any non-removable metal device (e.g., pacemaker, cochlear implants, stents, surgical clips, non-removable piercings)
  15. * Any prior eye injury or the potential of a foreign body in the eye (e.g., worked in metal fields)
  16. * Persistent functional impairment due to a head trauma
  17. * Fear of closed spaces
  18. * Any other contraindications for MRI (e.g., large tattoos on head and neck)
  19. * Previously participated in other "Pain Perception in the Brain" Studies in Colloca lab Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines, and THC)

Contacts and Locations

Study Contact

Research Coordinator
CONTACT
410-706-5975
NRSCollocaLab@umaryland.edu
Adria Suhr
CONTACT
asuhr@umaryland.edu

Principal Investigator

Luana Colloca, MD/PhD/MS
PRINCIPAL_INVESTIGATOR
University of Maryland Baltimore School of Nursing

Study Locations (Sites)

University of Maryland
Baltimore, Maryland, 21201-1512
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Luana Colloca, MD/PhD/MS, PRINCIPAL_INVESTIGATOR, University of Maryland Baltimore School of Nursing

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 Date2021-11-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Naloxone
  • fMRI
  • EEG
  • Observation
  • Healthy Volunteers

Additional Relevant MeSH Terms

  • Pain
  • Virtual Reality
  • Placebo