TMS for Complex Regional Pain Syndrome

NCT ID: NCT03137472

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2026-06-29

Brief Summary

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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.

Detailed Description

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Conditions

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Complex Regional Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single, blinding of participant

Study Groups

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Active Treatment

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

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Sham Treatment

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

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Interventions

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Transcranial Magnetic Stimulation (TMS)

The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Redlich Pain Endowment

UNKNOWN

Sponsor Role collaborator

Rocky Mountain Foundation

UNKNOWN

Sponsor Role collaborator

The Feldman Family Foundation Pain Research Fund

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Chief, Division of Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Pain Management Center

Redwood City, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Omar Altirkawi

Role: CONTACT

(650) 497-0485

Facility Contacts

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Birute Gedrimaite

Role: primary

650-497-0485

Other Identifiers

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25894-3

Identifier Type: -

Identifier Source: org_study_id

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