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

NCT ID: NCT01030133

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-02-28

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Real TMS

Participants in the real Transcranial Magnetic Stimulation (TMS) group will receive real stimulation across all interventions; the operator role Real TMS and receiver role Real TMS. rTMS will be used to stimulate the left prefrontal cortex using two Neuronetics TMS machines with figure-8, iron core coils at 10Hz and at 110% of resting motor threshold \[5 second trains following each trial (25 trials per visit)\].

Group Type: ACTIVE_COMPARATOR

Operator Role Real TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

Receiver Role Real TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the receiver condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.

Sham TMS

Participants in the sham Transcranial Magnetic Stimulation (TMS) group will receive sham stimulation across all interventions; the operator role Sham TMS and receiver role Sham TMS. Sham Stimulation involves 5 second trains of 10Hz rTMS in pairs alternating between real TMS and eSham TMS (randomly ordered). All sham treatment will be delivered with a specially designed, manufacture-provided sham TMS coil that looks and sounds identical to a real TMS coil but no magnetic current is transferred to the participant.

Group Type: SHAM_COMPARATOR

Operator Role Sham TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

Receiver Role Sham TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the receiver condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.

All Participants Operator Role

All participants in Operator Role (Receiving real or sham TMS)

Group Type: OTHER

Operator Role Real TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

Operator Role Sham TMS

Intervention Type: DEVICE

In two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

All Participants Operator Role

Intervention Type: DEVICE

All participants in Operator Role (Receiving real or sham TMS)

Interventions

Operator Role Real TMS

In two of the four visits, the participant will be assigned to the operator condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

Intervention Type: DEVICE

Receiver Role Real TMS

In two of the four visits, the participant will be assigned to the receiver condition receiving Real TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.

Intervention Type: DEVICE

Operator Role Sham TMS

In two of the four visits, the participant will be assigned to the operator condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "operator's" performance will control the painfulness delivered to both participants. Each participant will play each role twice.

Intervention Type: DEVICE

Receiver Role Sham TMS

In two of the four visits, the participant will be assigned to the receiver condition receiving Sham TMS. The participant will be assigned a partner and both participants will participate in a numeric-combination-guessing task. Performance on this task will be directly related to the painfulness of a series of thermal stimuli that participants receive. The "receiver's" performance on the task will be unrelated to his/her stimulus painfulness. Each participant will play each role twice.

Intervention Type: DEVICE

All Participants Operator Role

All participants in Operator Role (Receiving real or sham TMS)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey J Borckardt, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21122992 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/21122992

Article titled Fast left prefrontal rTMS acutely suppresses analgesic effects of perceived controllability on the emotional component of pain experience

Other Identifiers

Borckardt_19079

Identifier Type: -

Identifier Source: org_study_id