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Completed

NCT Number: NCT01588197

Real-Time fMRI Feedback Effects on Pain Perception

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.

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Key information

Conditions

Cognitive Pain Control Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attention/Distraction Strategy

Behavioral

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

Stimulus Quality/Severity Strategy

Behavioral

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.

Control Strategy

Behavioral

One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.

Primary outcomes

  1. Average Unpleasantness

    Time frame: 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"

  2. Average Pain Rating

    Time frame: 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"

  3. Ability to Distract

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2012
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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