TMS for Complex Regional Pain Syndrome

Stanford University

Status: Enrolling

Conditions: Complex Regional Pain Syndromes

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03137472

25894-3

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Active Treatment

Experimental group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Sham Treatment

Sham Comparator group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)