N-of-few Study of Pain Perception

NCT04664400 | Completed Results

• 2 other identifiers: 2301345R01MH076136
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A behavioral study that will examine how pain perception is affected by different types of conditioning and by context, with a few participants and multiple sessions ("N-of-few" design).

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Symbolic Learning)

  Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the symbolic learning procedure, cues are conditioned to different temperatures based on pictures of thermometers (instead of actual thermal stimuli as in the conditioning procedure). For the cues that were learned via symbolic learning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.

  Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.

• Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Conditioning)

  Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the conditioning procedure, cues are conditioned to different temperatures by delivering thermal stimuli with different temperatures after cues are presented (higher temperature following high cues and lower temperature following low cues). For the cues that were learned via conditioning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.

  Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.

• Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Instructions Only)

  Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the instructions only condition, cues are learned via verbal suggestion. For the cues that were learned via instructions only, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.

  Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.

• Within Participant Subjective Ratings of Acute Thermal Pain, When it is the Worse vs. the Better Alternative

  In the counterfactual task, participants are presented with two alternatives (either two pain levels, or one pain level and either losing or gaining a certain amount of money). In these pairs of alternatives, the medium level pain is sometimes the better option (i.e., when the alternative is losing money or a more intense pain stimulus) and sometimes the worse option (i.e., when the other alternative is gaining money or a less intense pain stimulus). One of the two options is chosen by the computer (participants have no control on this choice). The investigators will compare the pain ratings (scale 0-180) within participant for the same level pain stimulus (medium intensity) when it is the worse vs. the better option.

  Measured repeatedly during pain tasks, in each of the last 4 sessions of the experiment, immediately after thermal stimuli. Averaged across sessions and compared across conditions.

Other Outcomes (4)

• Within Participant Facial Expressions

  Measured continuously during pain stimuli in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability). Averaged and compared across conditions.

• Within Participant Thermal Imaging of the Face

  Measured continuously during pain stimuli in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability). Averaged and compared across conditions.

• Within Participant Changes in Skin Conductance Response Measured With a Biopac MP160 Device

  Measured continuously during pain stimuli in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability). Averaged and compared across conditions.

Study Arms (1)

N-of-few Study of Pain

EXPERIMENTAL

Behavioral: Symbolic conditioning; Behavioral: Conditioning; Behavioral: Instructions; Behavioral: Counterfactual

Interventions

Symbolic conditioning BEHAVIORAL

Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) through symbolic conditioning (no actual heat stimuli, only pictures of thermometers)

N-of-few Study of Pain

Conditioning BEHAVIORAL

Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from experience (with actual heat stimuli).

N-of-few Study of Pain

Instructions BEHAVIORAL

Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from verbal instructions.

N-of-few Study of Pain

Counterfactual BEHAVIORAL

Thermal stimuli will be either the better outcome or the worse outcome out of two possible outcomes.

N-of-few Study of Pain

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants

You may not qualify if:

• Cannot tolerate heat pain applied to the forearm/leg, based on a calibration task at the beginning of the experiment

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Results Point of Contact

• Title: Tor D Wager, PhD
• Organization: Dartmouth College

Tor.D.Wager@Dartmouth.edu

(603)-646-2196

Study Officials

• Tor D Wager, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diana L. Taylor Distinguished Professor

Model Details: Within-participant design with behavioral manipulations.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 11, 2020
• Study Start: January 22, 2021
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: April 18, 2023
• Results First Posted: November 18, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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)