TMS for Complex Regional Pain Syndrome

Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)

The aim of the current study is to assess the efficacy of TMS in the treatment of Complex Regional Pain Syndrome (CRPS). It is hypothesized that participants who receive TMS (Group 1) relative to sham treatment (Group 2) once daily for two days will demonstrate a greater improvement in CRPS-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. Participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.

Study Overview

• Status: Recruiting
• Conditions: Complex Regional Pain Syndromes
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (TMS)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birute Gedrimaite; Phone Number: (650) 497-0485; Email: birute@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94043
      • Recruiting
      • Stanford Pain Management Center
      • Contact: Birute Gedrimaite; Phone Number: 650-497-0485; Email: birute@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-70
• Diagnosis of CRPS (complex regional pain syndrome) for at least 3 months
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; Participants will receive active TMS in the target area once daily for two days	Device: Transcranial Magnetic Stimulation (TMS); The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
Sham Comparator: Sham Treatment; Participants will receive active TMS in a non-target area once daily for two days	Device: Transcranial Magnetic Stimulation (TMS); The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Decrease in CRPS-related Pain Ratings	1 week follow-up compared to baseline
Duration of Pain Relief	Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks	Duration from last treatment until pain returns - up to an estimate of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain-related Symptomology	Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)	Duration from last treatment until pain returns - up to an estimate of 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); Redlich Pain Endowment; Rocky Mountain Foundation; The Feldman Family Foundation Pain Research Fund

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Estimated): June 29, 2024
• Study Completion (Estimated): June 29, 2024

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: TMS, CRPS, Sham
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 25894-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No