Clinical trial NCT01030133: Effects of Transcranial Magnetic Stimulation (TMS) and Stimulus Controllability on Pain Perception
Official title: Effects of TMS and Stimulus Controllability on Pain Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.

Detailed description: Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual.1,2 A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons3,4 which induces electrical currents in the brain.5 If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).

rTMS over the prefrontal cortex has been shown to produce temporary analgesic effects in healthy adults using laboratory pain methods and in patients with chronic pain of various etiologies. However, little is known about mechanisms of action.

Evidence from functional MRI studies suggests that participants' perceived controllability over pain stimuli is associated with decreased pain experience and decreased activation of cortical and subcortical areas involved with pain perception.6 Perceived controllability may involved prefrontal cortical circuits and may be involved in inhibition of limbic system responses to painful stimuli.

To date, no studies have investigated the interaction between prefrontal TMS and perceived controllability on pain perception in healthy adults. Building on extensive pilot work and experience in the area of laboratory pain assessment and TMS in the Brain Stimulation Laboratory at MUSC, the investigators propose to investigate the effects of perceived controllability and prefrontal TMS on pain perception in healthy adults. This study may help determine whether TMS can be used to stimulate a cortical area thought to be involved in perceived controllability, thus enhancing one's sense of controllability and thereby substantially reduce pain intensity and unpleasantness.

Although transcranial magnetic stimulation (TMS) is now considered a minimal risk intervention, is approved for the treatment of depression, and is widely used around the world, little is known about mechanisms of action of prefrontal rTMS for depression or pain. There is some evidence that the prefrontal cortex is involved in perception of control and may moderate the effects of perceived controllability on emotional reactivity to painful stimuli. The present study aims to investigate the effects of prefrontal rTMS and perceived controllability on pain perception in healthy adults.

Eligibility criteria: Inclusion Criteria:

* 18-75 years of age

Exclusion Criteria:

* history of seizures or epilepsy
* family history of seizures
* history of chronic pain conditions
* current depression
* anxiety disorders
* taking any medications shown to lower seizure threshold
* metal implants above the waist
* pregnant
* brain tumors or lesions
* pacemaker

Primary outcomes:
measure: Pain Unpleasantness During Perceived Control Condition
timeFrame: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
measure: Pain Intensity During Perceived Control Condition
timeFrame: 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS
Secondary outcomes:
measure: Number of Participants That Correctly Guessed Their TMS Condition Assignment
timeFrame: After Pain Control Paradigm
measure: Confidence Ratings of Guessing TMS Condition Assignment
timeFrame: After Pain Control Paradigm
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Brain Stimulation Laboratory, Institute of Psychiatry
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffrey J Borckardt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borckardt JJ, Reeves ST, Frohman H, Madan A, Jensen MP, Patterson D, Barth K, Smith RA, Gracely R, George MS. Fast left prefrontal rTMS acutely suppresses analgesic effects of perceived controllability on the emotional component of pain experience. Pain. 2011 Jan;152(1):182-187. doi: 10.1016/j.pain.2010.10.018. Epub 2010 Nov 30.