Cognitive Pain Control
Conditions
Keywords
Pain, fMRI, real time
Brief summary
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
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.
Interventions
BEHAVIORALAttention/Distraction 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
BEHAVIORALStimulus Quality/Severity Strategy
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.
BEHAVIORALControl Strategy
One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Unpleasantness | Before and After fMRI Paradigm, an average of 2 hours | 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 |
| Average Pain Rating | Before and After fMRI Paradigm, an average of 2 hours | 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 |
| Ability to Distract | Before and After fMRI Paradigm, an average of 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACC Real Time fMRI Feedback 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. | 9 |
| PFC Real Time fMRI Feedback 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. | 9 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | No MRI | 1 | 0 |
Baseline characteristics
| Characteristic | ACC Real Time fMRI Feedback | PFC Real Time fMRI Feedback | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age, Continuous | 28 years STANDARD_DEVIATION 7.65 | 24.78 years STANDARD_DEVIATION 3.9 | 26.39 years STANDARD_DEVIATION 5.95 |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 8 Participants | 9 Participants | 17 Participants |
| Region of Enrollment United States | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC Real Time fMRI Feedback | Ability to Distract | Before fMRI Paradigm | 4.92 units on a scale | Standard Deviation 1.96 |
| ACC Real Time fMRI Feedback | Ability to Distract | After fMRI Paradigm | 4.41 units on a scale | Standard Deviation 2.15 |
| PFC Real Time fMRI Feedback | Ability to Distract | Before fMRI Paradigm | 3.83 units on a scale | Standard Deviation 1.25 |
| PFC Real Time fMRI Feedback | Ability to Distract | After fMRI Paradigm | 4.02 units on a scale | Standard Deviation 1.72 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC Real Time fMRI Feedback | Average Pain Rating | Before fMRI Paradigm | 3.79 units on a scale | Standard Deviation 2.2 |
| ACC Real Time fMRI Feedback | Average Pain Rating | After fMRI Paradigm | 3.88 units on a scale | Standard Deviation 2.21 |
| PFC Real Time fMRI Feedback | Average Pain Rating | Before fMRI Paradigm | 3.64 units on a scale | Standard Deviation 2.3 |
| PFC Real Time fMRI Feedback | Average Pain Rating | After fMRI Paradigm | 4.43 units on a scale | Standard Deviation 2.23 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC Real Time fMRI Feedback | Average Unpleasantness | Before fMRI Paradigm | 3.75 units on a scale | Standard Deviation 2.48 |
| ACC Real Time fMRI Feedback | Average Unpleasantness | After fMRI Paradigm | 3.30 units on a scale | Standard Deviation 2.39 |
| PFC Real Time fMRI Feedback | Average Unpleasantness | Before fMRI Paradigm | 3.56 units on a scale | Standard Deviation 2.22 |
| PFC Real Time fMRI Feedback | Average Unpleasantness | After fMRI Paradigm | 4.28 units on a scale | Standard Deviation 2.82 |