TMS for CRPS - Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.

Conditions
-----------------
Complex Regional Pain Syndrome (CRPS)

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Diagnosis of CRPS (complex regional pain syndrome) 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS Intervention - 5 days<br>Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days. | Device: Transcranial Magnetic Stimulation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable | Baseline to post-TMS day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Function and Coordination | As assessed by functional capacity exam and physical exam | End of 5-day treatment series and at 1-week follow-up relative to baseline | 
| Change in Sensory Perception |  | End of each treatment session and at 1-week follow-up as compared to baseline | 
| Change in Vasomotor Function |  | End of each treatment session and at 1-week follow-up as compared to baseline | 
| Change in Sudomotor Function |  | End of each treatment session and at 1-week follow-up as compared to baseline | 
| Trophic Changes |  | End of each treatment session and at 1-week follow-up as compared to baseline | 
| Change in Motor Strength and Joint Range of Motion |  | End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline |