Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

April 26, 2012 updated by: Medical University of South Carolina
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.

The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.

Participants with Neuropathic Pain:

After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.

The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).

Healthy Volunteers:

In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For Healthy Adults:

  • Between age of 21 and 60
  • No prescription medications in previous 3 months
  • No seizure history
  • No depression
  • Not suicidal
  • No anxiety
  • No hospitalizations or surgeries in previous 6 months
  • No history of chronic pain conditions
  • No implanted metal devices (e.g., pacemakers, metal plates, wires)
  • Not pregnant
  • No alcohol abuse/dependence history in previous 6 months
  • No illicit drug use in previous 6 months
  • Capable of reading, writing, giving consent, following instructions
  • No history of brain surgery or history of loss of consciousness >15 minutes
  • No history of autoimmune or endocrine disorder
  • No significant anxiety about entering MRI scanner

For Patients with neuropathic pain:

  • Between age of 21 and 75
  • No seizure history
  • Not taking medications shown to increase seizure risk (6 months)
  • Not suicidal
  • No hospitalizations or surgeries in previous 3 months
  • No implanted metal devices (e.g., pacemakers, metal plates, wires)
  • Not pregnant
  • No alcohol abuse/dependence history in previous 6 months
  • No illicit drug use in previous 6 months
  • Capable of reading, writing, giving consent, following instructions
  • Chronic pain (>6 months), not significantly relieved by pharmacological treatment
  • No significant anxiety about entering MRI scanner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
laboratory pain assessment
Device: laboratory pain assessment
Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
Active Comparator: 2
transcranial magnetic stimulation
Procedure: transcranial magnetic stimulation
There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
Time Frame: measured during the study period
measured during the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Jeffrey J. Borckardt, Ph.D., Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23NS050485-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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