TMS for CRPS - Pilot Study

March 30, 2017 updated by: Sean Mackey, Stanford University
The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Diagnosis of CRPS (complex regional pain syndrome)
  3. Average pain level reported on Numerical Rating Scale meets entry criteria
  4. Ability to perform the experimental task and procedures.

Exclusion Criteria:

  1. MRI contraindication (metal implants or devices, claustrophobia)
  2. TMS Contraindication (eg metal implant or devices near the site of stimulation)
  3. History of epilepsy
  4. History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
  5. Neurologic illness that would interfere with brain integrity
  6. Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
  7. Currently pregnant or planning to become pregnant.
  8. 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS Intervention - 5 days
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Device: Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: Baseline to post-TMS day 5
Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable
Baseline to post-TMS day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor Function and Coordination
Time Frame: End of 5-day treatment series and at 1-week follow-up relative to baseline
As assessed by functional capacity exam and physical exam
End of 5-day treatment series and at 1-week follow-up relative to baseline
Change in Sensory Perception
Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline
End of each treatment session and at 1-week follow-up as compared to baseline
Change in Vasomotor Function
Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline
End of each treatment session and at 1-week follow-up as compared to baseline
Change in Sudomotor Function
Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline
End of each treatment session and at 1-week follow-up as compared to baseline
Trophic Changes
Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline
End of each treatment session and at 1-week follow-up as compared to baseline
Change in Motor Strength and Joint Range of Motion
Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline
End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline

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

July 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25894

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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