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TMS for CRPS - Pilot Study

This study has been completed.
Information provided by (Responsible Party):
Sean Mackey, Stanford University Identifier:
First received: August 16, 2013
Last updated: March 30, 2017
Last verified: March 2017
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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Stanford University:

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

Secondary Outcome Measures:
  • 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

  • Change in Sensory Perception [ Time Frame: 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 ]
  • Change in Sudomotor Function [ Time Frame: 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 ]
  • 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 ]

Enrollment: 4
Study Start Date: July 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS Intervention - 5 days
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.
Device: Transcranial Magnetic Stimulation


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

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.
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Please refer to this study by its identifier: NCT01926119

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

Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University Identifier: NCT01926119     History of Changes
Other Study ID Numbers: 25894
Study First Received: August 16, 2013
Results First Received: November 17, 2015
Last Updated: March 30, 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 processed this record on May 25, 2017