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TMS for CRPS - Pilot Study

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ClinicalTrials.gov Identifier: NCT01926119
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Brief Summary:
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 or disease Intervention/treatment
Complex Regional Pain Syndrome (CRPS) Device: Transcranial Magnetic Stimulation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2013
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Change in Sensory Perception [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
  3. Change in Vasomotor Function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
  4. Change in Sudomotor Function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
  5. Trophic Changes [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
  6. 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 ]


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:

  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.

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): NCT01926119


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

Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01926119     History of Changes
Other Study ID Numbers: 25894
First Posted: August 20, 2013    Key Record Dates
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017
Last Verified: March 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