Effects of Transcranial Magnetic Stimulation (TMS) and Stimulus Controllability on Pain Perception

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Medical University of South Carolina.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01030133
First received: December 9, 2009
Last updated: December 22, 2010
Last verified: December 2010

December 9, 2009
December 22, 2010
October 2009
January 2010   (final data collection date for primary outcome measure)
Pain ratings [ Time Frame: two hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01030133 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Transcranial Magnetic Stimulation (TMS) and Stimulus Controllability on Pain Perception
Effects of TMS and Stimulus Controllability on Pain Perception

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Pain
Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation
  • Active Comparator: Real TMS
    Intervention: Device: Transcranial Magnetic Stimulation
  • Sham Comparator: Sham TMS
    Intervention: Device: Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030133
Borckardt_19079
No
Jeffrey J Borckardt, Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Jeffrey J Borckardt, PhD Medical University of South Carolina
Medical University of South Carolina
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP