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Trial record 4 of 133 for:    Complex Regional Pain Syndrome

TMS for Complex Regional Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03137472
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Redlich Pain Endowment
Rocky Mountain Foundation
The Feldman Family Foundation Pain Research Fund
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Brief Summary:
The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Device: Transcranial Magnetic Stimulation (TMS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single, blinding of participant
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : June 29, 2019
Estimated Study Completion Date : June 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Treatment
Participants will receive active TMS in the target area once daily for two days
Device: Transcranial Magnetic Stimulation (TMS)
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Sham Comparator: Sham Treatment
Participants will receive active TMS in a non-target area once daily for two days
Device: Transcranial Magnetic Stimulation (TMS)
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).




Primary Outcome Measures :
  1. Change in Pain [ Time Frame: 1 week follow-up compared to baseline ]
    Decrease in CRPS-related Pain Ratings

  2. Duration of Pain Relief [ Time Frame: Duration from last treatment until pain returns - up to an estimate of 6 months ]
    Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks


Secondary Outcome Measures :
  1. Change in Pain-related Symptomology [ Time Frame: Duration from last treatment until pain returns - up to an estimate of 6 months ]
    Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70
  • Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
  • Average pain level reported on Numerical Rating Scale meets entry criteria
  • Ability to perform the experimental task and procedures.

Exclusion Criteria:

  • MRI contraindication (metal implants or devices, claustrophobia)
  • TMS Contraindication (eg metal implant or devices near the site of stimulation)
  • History of epilepsy
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137472


Contacts
Contact: Kristen H Scherrer 650-724-2091 khymel@stanford.edu

Locations
United States, California
Stanford Pain Management Center Recruiting
Redwood City, California, United States, 94043
Contact: Kristen H Scherrer    650-724-2091    khymel@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Redlich Pain Endowment
Rocky Mountain Foundation
The Feldman Family Foundation Pain Research Fund

Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03137472     History of Changes
Other Study ID Numbers: 25894-3
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sean Mackey, Stanford University:
TMS, CRPS, Sham

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases