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

NCT04653064 | Recruiting

• 1 other identifier: 230135
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Contrasts of pain valence (i.e., unpleasantness) using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.

  Self-reported pain valence using the LMS ranging from 0-10 (with 0 representing "no pain" and 10 representing "most unlikable pain of any kind experienced".

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

• Contrast of pain intensity using the Bartoshuk Labeled Magnitude Scale (LMS) between body sites administered Placebo vs. Control Cream, both prior to and during pain delivery.

  Self-reported pain intensity using the LMS ranging from 0-10 (with 0 representing "not intense" and 10 representing "most intense pain of any kind experienced".

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

Secondary Outcomes (3)

• Contrasts of activation of fMRI aversiveness signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

• Contrasts of activation of fMRI sensation signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

• Contrasts of activation of eight fMRI somatotopic signatures between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

Other Outcomes (1)

• Contrast of scalar activation of Neurologic Pain Signature between trials where Placebo-cream-applied body sites are stimulated vs. trials where Control-cream-applied body sites are stimulated, both prior to and during pain delivery.

  Hour 2 of fMRI scanning, immediately after each pain delivery trial.

Study Arms (2)

Placebo Cream first

EXPERIMENTAL

Each participant will undergo thermal pain tasks after being administered a "treatment" cream to one of eight body sites.

Behavioral: Placebo Cream; Behavioral: Control Cream

Control Cream first

EXPERIMENTAL

Each participant will undergo thermal pain tasks after being administered a "control" cream to one of eight body sites.

Behavioral: Placebo Cream; Behavioral: Control Cream

Interventions

Placebo Cream BEHAVIORAL

Approximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as being analgesic.

Control Cream first; Placebo Cream first

Control Cream BEHAVIORAL

Approximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as one of no effect.

Control Cream first; Placebo Cream first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be a volunteer with a minimum age of 18 years and must be able and willing to provide written informed consent.
• If female, the subject must be non-lactating, not pregnant, and using a reliable contraception method.
• Subject must be able to read and speak English.
• Subject must be able to understand and follow the instructions of the investigator and understand all screening questionnaires.
• Subject must have no current or recent history of pathological pain.
• Subject must have abstained from alcohol and substance use for 48 hours.
• Subject must pass all fMRI screening tests.

You may not qualify if:

• If female, pregnancy.
• Inability to tolerate the scanning procedures (e.g., claustrophobia).
• Metal in body or prior history working with metal fragments (e.g., as a machinist).
• Inability to tolerate heat pain applied to the forearm.
• Reporting temporary abnormal levels of pain.
• Allergic response to the exfoliating cream.
• Current presence of pain.
• Current or past history of psychoactive substance abuse or dependence.
• Dementias.
• Movement disorders except familial tremor.
• CNS infection.
• CNS vasculitis.
• Inflammatory disease or autoimmune disease.
• CNS demyelinating disease (e.g. multiple sclerosis).
• Space occupying lesions (mass lesions, tumors).

Sponsors & Collaborators

• Trustees of Dartmouth College: lead

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tor D Wager, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tor D Wager, PhD

CONTACT

603-646-2196; Tor.D.Wager@Dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diana L. Taylor Distinguished Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 4, 2020
• Study Start: March 19, 2021
• Primary Completion: February 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: All data will be de-identified prior to sharing. Raw data will be submitted to NDA within one year from the end of data collection or 6 months from the acceptance date of the first primary study manuscript on the full dataset (excluding methods development papers), whichever is later. Analyzed data/maps of statistical results and models accompanying each paper will be submitted to NDA/OpenFMRI when the primary study manuscript is accepted. All data will be shared indefinitely.
• Access Criteria: These data would generally be made available to any qualified investigator for neuroimaging studies only including: i. Research on any brain phenomenon; ii. Neuroimaging research on non-disease traits (intelligence, behavioral traits); iii. Methods development research. The requesting investigator must provide documentation of local IRB approval. These data would not be made available to: i. Any criminal justice organization, because data may not be used for any criminal justice applications; ii. Any commercial entity, because use of the data is limited to not-for-profit organizations and data may not be used for any commercial purposes.

Locations

US (1)