TMS for Complex Regional Pain Syndrome

Study Overview
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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.

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

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation (TMS)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, CRPS, Sham