NCT06986122

Brief Summary

This study investigates how spatial context and perceived controllability modulate pain, affective states such as anxiety, and motivated behavior. The study examines how control over pain and threat-related environments influences pain perception, state anxiety, associated autonomic responses, and behavior. The main questions it aims to answer are: Does having control over pain within specific contexts alter how much pain people feel-even when the stimulus intensity remains constant? How do different types of environments (safe, controllable, or uncontrollable) shape pain-related brain activity, subjective anxiety, and physiological arousal? How do people perform cognitively demanding or distracting tasks (and retain their memory) when under threat versus when in control? Lastly, how do these learned associations with spatial contexts persist or adapt when environmental contingencies are explicitly changed? Taken together, exploration of these factors may lay the groundwork for understanding how placebo-related mechanisms-including perceived control, contextual learning, emotional engagement, and distraction-interact to shape pain and anxiety in complex environments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
38mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Jun 2029

First Submitted

Initial submission to the registry

May 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2029

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

May 8, 2025

Last Update Submit

October 29, 2025

Conditions

Keywords

Place conditioningcontrollability of pain

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity Ratings

    Self-reported pain level following each thermal stimulus, measured on a visual analog scale. 0-100 scale with 0 indicating no pain and higher values indicating more pain.

    3-10 sec post-stimulus throughout testing sessions, on average complete within 1 month

  • Self-Reported Anxiety Ratings

    Participants rate their current level of anxiety using a 0-100 visual analogue Subjective Units of Distress Scale (SUDS). 0 indicates no anxiety and higher values indicating more anxiety.

    Every 45-60 sec throughout testing sessions, on average complete within 1 month

Study Arms (1)

Contextual learning

EXPERIMENTAL

All participants complete trials in three virtual contexts (safe, controllable threat, uncontrollable threat), with pain controllability and task performance assessed across all conditions in a randomized within-subject design.

Behavioral: Pain Threat ManipulationBehavioral: Pain Controllability Manipulation

Interventions

Participants receive brief thermal pain stimuli in certain virtual environments to examine how threat influences perception and physiological responses.

Contextual learning

In some contexts, participants can reduce or avoid pain using a button; in others, no action changes the outcome. This manipulation is used to study the effects of perceived control over pain.

Contextual learning

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* No self-reported current or history of depression, bipolar disorder, or other psychiatric diagnosis * No self-reported current seizure disorder (i.e., seizure within past 10 years), or history of stroke or other major neurological diagnosis * No self-reported current chronic pain, or acute pain within three months of the study period * No current migraine disorder (i.e., 15 headache days or more in 1 month) * No use of central nervous system-effective medication or other medication for neurological/psychiatric treatment * No self-reported substance abuse within the last six months * No contraindication to MRI (e.g., pregnancy, claustrophobia, pacemakers, ear/cochlear implants, shrapnel injuries, clips, or other ferromagnetic/electrical objects/devices, diagnosed brain abnormality such as tumor, or skin lesions on the scalp.) * No contraindications for induced pain (e.g., no heart disease, high blood pressure, heart surgery, heart problems of any kind, severe asthma, respiratory problems of any kind, fibromyalgia, Raynaud's Syndrome or Disease, chronic pain, diabetes) * Participants must be capable of performing experimental tasks (e.g., are able to read), are fluent or native speakers of English * Participants must be able to tolerate the maximum level of thermal pain stimuli (for thermal stimuli)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

RECRUITING

Related Publications (7)

  • Tzschentke TM. Measuring reward with the conditioned place preference paradigm: a comprehensive review of drug effects, recent progress and new issues. Prog Neurobiol. 1998 Dec;56(6):613-72. doi: 10.1016/s0301-0082(98)00060-4.

    PMID: 9871940BACKGROUND
  • Salomons TV, Nusslock R, Detloff A, Johnstone T, Davidson RJ. Neural emotion regulation circuitry underlying anxiolytic effects of perceived control over pain. J Cogn Neurosci. 2015 Feb;27(2):222-33. doi: 10.1162/jocn_a_00702.

    PMID: 25208742BACKGROUND
  • Salomons TV, Johnstone T, Backonja MM, Davidson RJ. Perceived controllability modulates the neural response to pain. J Neurosci. 2004 Aug 11;24(32):7199-203. doi: 10.1523/JNEUROSCI.1315-04.2004.

    PMID: 15306654BACKGROUND
  • Kragel PA, Kano M, Van Oudenhove L, Ly HG, Dupont P, Rubio A, Delon-Martin C, Bonaz BL, Manuck SB, Gianaros PJ, Ceko M, Reynolds Losin EA, Woo CW, Nichols TE, Wager TD. Generalizable representations of pain, cognitive control, and negative emotion in medial frontal cortex. Nat Neurosci. 2018 Feb;21(2):283-289. doi: 10.1038/s41593-017-0051-7. Epub 2018 Jan 1.

    PMID: 29292378BACKGROUND
  • Atlas LY, Bolger N, Lindquist MA, Wager TD. Brain mediators of predictive cue effects on perceived pain. J Neurosci. 2010 Sep 29;30(39):12964-77. doi: 10.1523/JNEUROSCI.0057-10.2010.

    PMID: 20881115BACKGROUND
  • Amat J, Baratta MV, Paul E, Bland ST, Watkins LR, Maier SF. Medial prefrontal cortex determines how stressor controllability affects behavior and dorsal raphe nucleus. Nat Neurosci. 2005 Mar;8(3):365-71. doi: 10.1038/nn1399. Epub 2005 Feb 6.

    PMID: 15696163BACKGROUND
  • Alvarez RP, Biggs A, Chen G, Pine DS, Grillon C. Contextual fear conditioning in humans: cortical-hippocampal and amygdala contributions. J Neurosci. 2008 Jun 11;28(24):6211-9. doi: 10.1523/JNEUROSCI.1246-08.2008.

    PMID: 18550763BACKGROUND

MeSH Terms

Conditions

AgnosiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Vivek Sagar, PhD

CONTACT

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 in Neuroscience

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 22, 2025

Study Start

October 28, 2025

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2029

Last Updated

October 31, 2025

Record last verified: 2025-10

Locations