An interventional study of Attention/Distraction Strategy and Stimulus Quality/Severity Strategy in Cognitive Pain Control, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-14.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Other
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.
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.
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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 · Behavioral: Stimulus Quality/Severity Strategy · Behavioral: Control Strategy
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 · Behavioral: Stimulus Quality/Severity Strategy · Behavioral: Control Strategy
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
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.
One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.
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"
Time frame: 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"
Time frame: 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.
Time frame: Before and After fMRI Paradigm, an average of 2 hours
| Milestone | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback |
|---|---|---|
| Started | 10 | 10 |
| Completed | 9 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: No mri | 1 | 0 |
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"
| units on a scale | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback |
|---|---|---|
| Before fMRI Paradigm | 3.75 ± 2.48 | 3.56 ± 2.22 |
| After fMRI Paradigm | 3.30 ± 2.39 | 4.28 ± 2.82 |
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"
| units on a scale | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback |
|---|---|---|
| Before fMRI Paradigm | 3.79 ± 2.20 | 3.64 ± 2.30 |
| After fMRI Paradigm | 3.88 ± 2.21 | 4.43 ± 2.23 |
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.
| units on a scale | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback |
|---|---|---|
| Before fMRI Paradigm | 4.92 ± 1.96 | 3.83 ± 1.25 |
| After fMRI Paradigm | 4.41 ± 2.15 | 4.02 ± 1.72 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real Time fMRI Feedback | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| No Feedback | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
2 participants did not complete MRI scanning and so were not included in analyses
| Age, Categorical(Participants) | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 18 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| Mean | 28 ± 7.65 | 24.78 ± 3.90 | 26.39 ± 5.95 |
| Sex: Female, Male(Participants) | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 4 | 5 | 9 |
| Race/Ethnicity, Customized(Participants) | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| White Non-Hispanic | 8 | 9 | 17 |
| Black or African American | 1 | 0 | 1 |
| Region of Enrollment(Participants) | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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