Transcranial Magnetic Stimulation (TMS) for CRPS

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT02067273
First received: February 13, 2014
Last updated: July 17, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for CRPS

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in Pain [ Time Frame: End of each treatment session (up to 5 days) compared to baseline ] [ Designated as safety issue: No ]
    treatment session occurs either once, or once a day for 5 days in a row - depending on the arm. Pain at the end of each treatment session will be compared with the baseline pain report.

  • Change in Pain [ Time Frame: 1 week follow-up compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Pain Relief [ Time Frame: Duration from last treatment until pain returns - up to an estimate of 6 months ] [ Designated as safety issue: No ]
    Duration of pain relief after last treatment - measured as length of time until pain returns. Pain will be measured until it returns - this may be at any point (2 days, 1 week, 1 month, 3 months, etc.) - and we will keep assessing until that occurs.


Estimated Enrollment: 18
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS Intervention for 1 day
Application of Transcranial Magnetic Stimulation (TMS) for 1 day
Device: Transcranial Magnetic Stimulation (TMS)
Experimental: TMS Intervention for 5 days
Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days
Device: Transcranial Magnetic Stimulation (TMS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Sean Mackey, Chief, Division of Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02067273     History of Changes
Other Study ID Numbers: 25894-2
Study First Received: February 13, 2014
Last Updated: July 17, 2014
Health Authority: United States: Federal Government
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 September 30, 2014