Real-Time fMRI Feedback Effects on Pain Perception

Study Overview
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Brief Summary
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The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.

Detailed Description
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Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein thermal pain stimuli will be used to elicit activation of the pain neuro-matrix. All participants will undergo thermal pain threshold testing before and after fMRI scan. Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied before fMRI and after fMRI. All participants will be given prompts to apply a set of cognitive pain-control strategies. Half of the participants will receive real-time fMRI feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC). It is hypothesized that those receiving real-time feedback of brain activity thought to be involved with analgesic effects will demonstrate greater analgesia associated with the application of the cognitive control techniques after fMRI paradigm (decreased pain intensity and unpleasantness ratings and increased thermal pain thresholds) than those who are not given feedback before fMRI paradigm.

Official Title
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Real-Time fMRI Feedback Effects on Pain Perception

Conditions
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Cognitive Pain Control

Intervention / Treatment
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* Behavioral: Attention/Distraction Strategy
* Behavioral: Stimulus Quality/Severity Strategy
* Behavioral: Control Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults ages 18-65 Exclusion Criteria: Clinical depression Anxiety Substance dependence or chronic pain Ferrous metal implants Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACC Real Time fMRI Feedback<br>Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display. | Behavioral: Attention/Distraction Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body). Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience<br>Behavioral: Stimulus Quality/Severity Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain. Attempt to perceive the stimulus as low intensity rather than high intensity.<br>Behavioral: Control Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.<br>|
| Experimental: PFC Real Time fMRI Feedback<br>Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to focus on the thermal stimuli for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display. | Behavioral: Attention/Distraction Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body). Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience<br>Behavioral: Stimulus Quality/Severity Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain. Attempt to perceive the stimulus as low intensity rather than high intensity.<br>Behavioral: Control Strategy<br>* One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Unpleasantness | All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI. Participants will be asked to rate pain unpleasantness, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI). 0=no unpleasantness and 10=worst unpleasantness imaginable | Before and After fMRI Paradigm, an average of 2 hours | 
| Average Pain Rating | All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI scan.Participants will be asked to rate painfulness of the thermal stimuli applied, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI). 0=no pain and 10=worst pain imaginable | Before and After fMRI Paradigm, an average of 2 hours | 
| Ability to Distract | All participants will undergo thermal pain threshold testing before and after fMRI paradigm. Participants will rate the ability to distract themselves from the thermal stimuli, on a scale of 0-10, before fMRI paradigm (Baseline) and after fMRI paradigm, 0=not able to distract at all and 10=completely able to distract. A Higher rating represents greater ability to distract from thermal pain stimuli. | Before and After fMRI Paradigm, an average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, fMRI, real time