TMS for Complex Regional Pain Syndrome

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03137472

Collaborator

National Institutes of Health (NIH) (NIH), Redlich Pain Endowment (Other), Rocky Mountain Foundation (Other), The Feldman Family Foundation Pain Research Fund (Other)

Enrollment

Location

Arms

86.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndromes	Device: Transcranial Magnetic Stimulation (TMS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single, blinding of participant

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 24, 2017

Anticipated Primary Completion Date :

Jun 29, 2024

Anticipated Study Completion Date :

Jun 29, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Change in Pain [1 week follow-up compared to baseline]
Decrease in CRPS-related Pain Ratings
Duration of Pain Relief [Duration from last treatment until pain returns - up to an estimate of 6 months]
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 [Duration from last treatment until pain returns - up to an estimate of 6 months]
Decreases in Pain-related Symptomology (i.e., cognitive, emotional and physical)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Pain Management Center	Redwood City	California	United States	94043

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sean Mackey, Chief, Division of Pain Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT03137472

Other Study ID Numbers:

25894-3

First Posted:

May 2, 2017

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sean Mackey, Chief, Division of Pain Medicine, Stanford University

TMS, CRPS, Sham

Additional relevant MeSH terms:

Complex Regional Pain Syndromes

Reflex Sympathetic Dystrophy

Syndrome

Somatoform Disorders

Study Results

No Results Posted as of Jun 10, 2022