Transcranial Magnetic Stimulation for Low Back Pain

August 5, 2015 updated by: Sean Mackey, Stanford University

Clinical Applicaitons of Non-Invasive Brain Stimulation for the Treatment of Chronic Pain

The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older
  • Patient with Chronic Low Back Pain
  • Meets minimum pain level criteria
  • Ability to perform the experimental Task and Procedures

Exclusion Criteria:

  • MRI contraindication if an MRI exam is required per protocol
  • TMS Contraindication
  • History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
  • Neurologic illness that would interfere with brain integrity
  • Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
  • Currently pregnant or planning to become pregnant.
  • On going legal action or disability claim.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS Parameter Condition 1 first
Application of Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation
Experimental: TMS Parameter Condition 2 First
Application of Transcranial Magnetic Stimulation
Device: Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Average Daily Pain
Time Frame: Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)
Compared to baseline pain report as provided by Visual Analogue Scale (VAS)
Baseline Compared to each treatmeant series (at 4 weeks, 8 weeks, and 12 weeks)
Change in Worst Daily Pain
Time Frame: Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)
As compared to baseline worst daily pain report provided on visual analogue scale (VAS)
Baseline Compared to each treatment series (at 4 weeks, 8 weeks, and 12 weeks)

Collaborators and Investigators

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

Sponsor

Stanford University

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27678

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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