An interventional study of Instructions and Attention in Pain, Normal Physiology and Healthy Volunteers, sponsored by National Center for Complementary and Integrative Health (NCCIH). Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Not applicable, Interventional, and Basic science
Background:
- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision.
Objectives:
- To better understand how pain and emotions are processed and influenced by psychological factors.
Eligibility:
- Healthy volunteers ages 18-50.
Design:
Objective
Pain is one of the most important signals for an organism s survival. The pathways that transfer noxious input from the periphery to the central nervous system are highly conserved across human and animal models. In humans, the ultimate experience of pain is also highly influenced by psychological factors. For example, the placebo effect leads to robust pain relief and can influence responses to noxious stimuli in the human brain. However, the psychological and neurobiological mechanisms by which psychological factors influence pain remain largely unknown.
Pain can be modulated by explicit beliefs about treatments, prior experience and learning, interpersonal processes that support the patient-provider relationship, and contextual factors related to the treatment environment. In the proposed series of experiments, we will systematically investigate the neural and psychological mechanisms that mediate the effects of these factors on acute pain. We will focus on expectations, attention, emotion, conditioning/associative learning, and social factors. These experiments will principally use functional magnetic resonance imaging (fMRI) and psychophysiological measurements, as well as behavioral assays and self-reports. We will examine the effects of different types of pain-related expectations on decisions about pain as well as responses in the brain and periphery. We will also compare acute pain with other hedonic and perceptual processes. This will allow us to distinguish processes that are unique to pain perception from those that are not specific to pain, such as processes involved in perception and decision-making across domains.
Together, the proposed series of experiments aim to elucidate the psychological, neurobiological, and physiological mechanisms that modulate pain. This, in turn, can identify targets for pain treatment and inform mechanistic studies of altered pain processing in clinical populations.
Study Population
We plan to recruit 550 healthy volunteers between age 18 and 50.
Design
The aim of the proposed series of experiments is to understand how expectations, attention, and emotion influence acute pain. We will manipulate expectations about noxious stimuli using associative learning and verbal instructions, in both within-subjects and between-groups designs. We will measure decisions about pain experience (self-report) as well as neural and physiological responses to noxious stimuli that cause pain. We will combine computational modeling with advanced neuroimaging analyses to isolate the neural and psychological mechanisms that mediate the effects of expectations, attention, and emotion on subjective pain. To determine the specificity of these mechanisms, we will compare acute pain modalities (e.g., thermal pain versus shock-induced pain), and we will contrast pain with other hedonic and perceptual domains (e.g., taste).
Outcome measures
Dependent variables for all experiments will include decisions about pain and/or other percepts (e.g., sweetness of a taste) measured with visual analogue scales, reaction time, physiological responses (e.g., skin conductance, pupil dilation), and/or BOLD activation in regions of interest. We are specifically interested in processes within the network of regions known to be involved in pain processing (pain-processing network, PPN), as well as responses in the prefrontal cortex (PFC), ventral striatum (VS), and amygdala. We hypothesize that nociceptive stimuli and pain ratings will be associated with unique patterns of activation within the PPN, whereas responses in regions associated with value, executive function, and decision-making will be common across outcomes.
EXCLUSION CRITERIA (all sub-studies):
EXCLUSION CRITERIA (fMRI sub-studies):
Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure or pain stimulation will be excluded from the MRI portion of the protocol, but may participate in the non-fMRI sessions (with the exception of pregnant women). Such conditions include:
EXCLUSION CRITERIA (placebo analgesia sub-studies):
-Participation in an NIH study of analgesia, as gleaned from CRIS.
Participants are instructed about outcomes
Behavioral: Instructions
Participants learn through experience
Behavioral: Instructions
Participants learn about heat outcomes through conditioning
Behavioral: Thermal Pain
Participants learn about salt outcomes through conditioning
Behavioral: Thermal Pain
Participants learn about sugar outcomes through conditioning
Behavioral: Thermal Pain
All participants experience all outcomes, within subjects designs
Participants are instructed to attend toward or away from the stimulus
Behavioral: Attention
Participants experience both placebo and cue-based expectations within subjects
Behavioral: Placebo instructions
In sub-study 1, half the participants are instructed about outcomes, half learn through experience.
In sub-study 4, participants learn about outcomes and we manipulate attention toward or away from the pain.
In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.
In sub-study 5, we test whether placebo effects and expectancy cues modulate pain through similar mechanisms.
Physiological responses (heart rate, skin conductance, respiration, pupil dilation, eye gaze position)
In behavioral and fMRI experiments, we measure autonomic responses in anticipation and response to painful and non-painful stimuli using non-invasive measures.
Time frame: During the study visit in response to painful and non-painful stimuli.
Pain perception (pain ratings)
Substudies of pain collect pain ratings using a visual analogue scale, either verbally or via computer.
Time frame: During the study visit in response to painful stimuli.
BOLD response in brain regions of interest measured using fMRI
FMRI substudies proceed following behavioral substudies. We measure brain responses in anticipation and response to painful and non-painful stimuli.
Time frame: During the study visit in response to painful and non-painful stimuli.
Questionnaire measures (e.g. State-trait anxiety index, Fear of Pain questionnaire, Intolerance of Uncertainty questionnaire, McGill Pain Questionnaire)
Personality measures that have been linked with pain and emotion will be tested as moderators of effects on the above outcomes.
Time frame: Trait measures are collected during initial screening visit ; State measures are collected on every visit
Plan to share: No — We will share deidentified data only as per language in the protocol.
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National Center for Complementary and Integrative Health (NCCIH)