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
  Purpose

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.


Condition Intervention
Pain
Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: Effects of TMS and Stimulus Controllability on Pain Perception

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Pain ratings [ Time Frame: two hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real TMS Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation
Sham Comparator: Sham TMS Device: Transcranial Magnetic Stimulation
Transcranial Magnetic Stimulation

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030133

Locations
United States, South Carolina
Brain Stimulation Laboratory, Institute of Psychiatry
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Jeffrey J Borckardt, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Jeffrey J Borckardt, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01030133     History of Changes
Other Study ID Numbers: Borckardt_19079
Study First Received: December 9, 2009
Last Updated: December 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
pain

ClinicalTrials.gov processed this record on August 28, 2014