RECRUITING

The Warmth, Anticipation, Sensation, Aversion, and Body-part Imaging Study

Conditions

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

This functional magnetic-resonance imaging study of the brain will feature a within-subject crossover design to investigate the effects of a placebo cream on painful thermal stimulation rendered upon eight body sites. The investigators aim to 1.) improve the understanding of how the brain represents thermal pain responses somatotopically (i.e., across different body-sites) 2.) to test these brain representations with and without the presence of a pain-targeted placebo intervention, and 3.) to examine how these brain representations change prior to vs. during the delivery of thermal pain. They predict that placebo cream will downregulate the intensity of aversive brain activity representations, and to a lesser degree, sensation and somatotopic representations, both prior to and during painful thermal stimulation.

Official Title

Placebo Effects on Anxiety and Pain

Quick Facts

Study Start:2021-03-19
Study Completion:2025-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04653064

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject must be a volunteer with a minimum age of 18 years and must be able and willing to provide written informed consent.
  2. * If female, the subject must be non-lactating, not pregnant, and using a reliable contraception method.
  3. * Subject must be able to read and speak English.
  4. * Subject must be able to understand and follow the instructions of the investigator and understand all screening questionnaires.
  5. * Subject must have no current or recent history of pathological pain.
  6. * Subject must have abstained from alcohol and substance use for 48 hours.
  7. * Subject must pass all fMRI screening tests.
  1. * If female, pregnancy.
  2. * Inability to tolerate the scanning procedures (e.g., claustrophobia).
  3. * Metal in body or prior history working with metal fragments (e.g., as a machinist).
  4. * Inability to tolerate heat pain applied to the forearm.
  5. * Reporting temporary abnormal levels of pain.
  6. * Allergic response to the exfoliating cream.
  7. * Current presence of pain.
  8. * Current or past history of psychoactive substance abuse or dependence.
  9. * Dementias.
  10. * Movement disorders except familial tremor.
  11. * CNS infection.
  12. * CNS vasculitis.
  13. * Inflammatory disease or autoimmune disease.
  14. * CNS demyelinating disease (e.g. multiple sclerosis).
  15. * Space occupying lesions (mass lesions, tumors).
  16. * Congenital CNS abnormality (e.g. cerebral palsy).
  17. * Seizure disorder.
  18. * History of closed head trauma with loss of consciousness.
  19. * History of cerebrovascular disease (stroke, TIAs).
  20. * Abnormal MRI (except changes accounted for by technical factors or UBOs.
  21. * Neuroendocrine disorders (e.g., Cushings disease).
  22. * Uncorrected hypothyroidism or hyperthyroidism.
  23. * Current or past history of cancer.
  24. * Recent history (within two years) of myocardial infarction, severe cardiovascular disease, or currently active cardiovascular disease (e.g. angina, cardiomyopathy).
  25. * Uncontrolled hypertension or hypotension.
  26. * Chronic pain syndromes.
  27. * Chronic fatigue syndromes.
  28. * A history of neurologic disease or neuropathic pain.
  29. * Prior treatment within the last month with any of the following: antidepressants, mood stabilizers, glucocorticoids, opiates.
  30. * Prior treatment with any of the following: antipsychotics, isoniazid, centrally active antihypertensive drugs (e.g. clonidine, reserpine).
  31. * Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
  32. * Current treatment for psychiatric disorders including mood, anxiety, substance abuse, attention-deficit/hyperactivity disorder (ADHD), psychosis.
  33. * Neurological disorders (e.g., taking dopamine agonists for Parkinson's) Cardiovascular disease or medication (e.g., taking ACE (angiotensin-converting-enzyme) inhibitors for cardiac remodeling).
  34. * Frequent smoking (\> 5 cigarettes / day).
  35. * Frequent alcohol use (\> 14 drinks / week).
  36. * Frequent migraines (\> 5 / month on average).

Contacts and Locations

Study Contact

Tor D Wager, PhD
CONTACT
603-646-2196
Tor.D.Wager@Dartmouth.edu

Principal Investigator

Tor D Wager, PhD
PRINCIPAL_INVESTIGATOR
Dartmouth College

Study Locations (Sites)

Dartmouth College
Hanover, New Hampshire, 03755
United States

Collaborators and Investigators

Sponsor: Trustees of Dartmouth College

  • Tor D Wager, PhD, PRINCIPAL_INVESTIGATOR, Dartmouth College

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 Date2021-03-19
Study Completion Date2025-12-26

Study Record Updates

Study Start Date2021-03-19
Study Completion Date2025-12-26

Terms related to this study

Additional Relevant MeSH Terms

  • Pain