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

NCT01030133 | Completed Results DMC FDA Device

• 1 other identifier: Borckardt_19079
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (2)

• Pain Unpleasantness During Perceived Control Condition

  The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials. Participants in the operator role group rated the unpleasantness of each thermal stimulus on a computerized visual analog scale (VAS). Unpleasantness ratings are on a scale of 0 to 100. 0=not unpleasant. 100=extremely unpleasant. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean unpleasantness rating for both groups during the perceived control condition.

  30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS

• Pain Intensity During Perceived Control Condition

  The perceived control condtion of the pain task consisted of 30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS). The entire pain task (perceived control condition and no control condition) consisted of 60 trials.), participants in the operator role group rated the pain intensity of each thermal stimulus on a computerized visual analog scale (VAS). Pain intensity ratings are on a scale of 0 to 100. 0=not painful. 100=extremely painful. The ratings were averaged over all trials for the perceived control condition for the Real TMS and Sham TMS group. The results below, report the mean pain intensity rating for both groups during the perceived control condition.

  30 trials of 1 to 4 seconds of thermal stimulus accompanied by 5 seconds of real or sham TMS

Secondary Outcomes (2)

• Number of Participants That Correctly Guessed Their TMS Condition Assignment

  After Pain Control Paradigm

• Confidence Ratings of Guessing TMS Condition Assignment

  After Pain Control Paradigm

Study Arms (3)

Real TMS

ACTIVE COMPARATOR

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 \[5 second trains following each trial (25 trials per visit)\].

Device: Operator Role Real TMS; Device: Receiver Role Real TMS

Sham TMS

SHAM COMPARATOR

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.

Device: Operator Role Sham TMS; Device: Receiver Role Sham TMS

All Participants Operator Role

OTHER

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

Device: Operator Role Real TMS; Device: Operator Role Sham TMS; Device: All Participants Operator Role

Interventions

Operator Role Real TMS 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.

All Participants Operator Role; Real TMS

Receiver Role Real TMS 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.

Real TMS

Operator Role Sham TMS 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; Sham TMS

Receiver Role Sham TMS 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.

Sham TMS

All Participants Operator Role DEVICE

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

All Participants Operator Role

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 21122992 RESULT

Related Links

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

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jeffery J Borckardt
• Organization: Medical University of South Carolina

borckardt@musc.edu

843.792.3127

Study Officials

• Jeffrey J Borckardt, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 28, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-08

Locations

US (1)