TMS for CRPS - Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT01926119
First received: August 16, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in pain [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up compared to baseline ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in vasomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] [ Designated as safety issue: No ]
  • Change in sudomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] [ Designated as safety issue: No ]
  • Trophic changes [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 - TBS followed by High Frequency
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Device: Transcranial Magnetic Stimulation
Experimental: TMS Intervention - High frequency stimulation followed by TBS
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of High Frequency stimulation followed by Theta Burst Stimulation
Device: Transcranial Magnetic Stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926119

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

No publications provided

Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01926119     History of Changes
Other Study ID Numbers: 25894
Study First Received: August 16, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 02, 2014