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TMS for Complex Regional Pain Syndrome

Primary Purpose

Complex Regional Pain Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring TMS, CRPS, Sham

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Pain Management CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Treatment

Sham Treatment

Arm Description

Participants will receive active TMS in the target area once daily for two days

Participants will receive active TMS in a non-target area once daily for two days

Outcomes

Primary Outcome Measures

Change in Pain
Decrease in CRPS-related Pain Ratings
Duration of Pain Relief
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks

Secondary Outcome Measures

Change in Pain-related Symptomology
Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)

Full Information

First Posted
April 28, 2017
Last Updated
June 8, 2022
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), Redlich Pain Endowment, Rocky Mountain Foundation, The Feldman Family Foundation Pain Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03137472
Brief Title
TMS for Complex Regional Pain Syndrome
Official Title
Transcranial Magnetic Stimulation (TMS) for Complex Regional Pain Syndrome (CRPS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
June 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH), Redlich Pain Endowment, Rocky Mountain Foundation, The Feldman Family Foundation Pain Research Fund

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes
Keywords
TMS, CRPS, Sham

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single, blinding of participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Participants will receive active TMS in the target area once daily for two days
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Participants will receive active TMS in a non-target area once daily for two days
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
Primary Outcome Measure Information:
Title
Change in Pain
Description
Decrease in CRPS-related Pain Ratings
Time Frame
1 week follow-up compared to baseline
Title
Duration of Pain Relief
Description
Duration of decreased CRPS-related pain ratings, measured as a length of time until pain returns for two consecutive weeks
Time Frame
Duration from last treatment until pain returns - up to an estimate of 6 months
Secondary Outcome Measure Information:
Title
Change in Pain-related Symptomology
Description
Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)
Time Frame
Duration from last treatment until pain returns - up to an estimate of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birute Gedrimaite
Phone
(650) 497-0485
Email
birute@stanford.edu
Facility Information:
Facility Name
Stanford Pain Management Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birute Gedrimaite
Phone
650-497-0485
Email
birute@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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TMS for Complex Regional Pain Syndrome

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