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Transcranial Magnetic Stimulation (TMS) for CRPS

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ClinicalTrials.gov Identifier: NCT02067273
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Complex Regional Pain Syndrome (CRPS) Device: Transcranial Magnetic Stimulation (TMS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for CRPS
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
More Information
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Additional Information:

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Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02067273    
Other Study ID Numbers: 25894-2
First Posted: February 20, 2014    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases