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Transcranial Magnetic Stimulation (TMS) for CRPS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02067273
First Posted: February 20, 2014
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
  Purpose
The purpose of this pilot study is to test the durability of response to Transcranial Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS for varying lengths of time in a pilot study to investigate what the clinical impact.

Condition Intervention
Complex Regional Pain Syndrome (CRPS) Device: Transcranial Magnetic Stimulation (TMS)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for CRPS

Resource links provided by NLM:


Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:
  • Present Pain Intensity [ Time Frame: Baseline, post-treatment, one week follow-up ]
    Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.


Enrollment: 20
Study Start Date: February 2014
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS Intervention for 5 days
Application of Transcranial Magnetic Stimulation (TMS) for up to 5 days
Device: Transcranial Magnetic Stimulation (TMS)
Experimental: TMS Intervention for 1 day
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Device: Transcranial Magnetic Stimulation (TMS)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of CRPS (complex regional pain syndrome)
  • 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.
  Contacts and Locations
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): NCT02067273


Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
  More Information

Additional Information:
Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02067273     History of Changes
Other Study ID Numbers: 25894-2
First Submitted: February 13, 2014
First Posted: February 20, 2014
Results First Submitted: April 3, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases