Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain

Study Overview
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Brief Summary
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The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain. The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.

Detailed Description
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The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

Official Title
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Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain

Conditions
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Peripheral Neuropathy, Neuropathic Pain

Intervention / Treatment
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* Device: Exablate treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 30 years or older Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care Subject has diagnosis of definite neuropathic pain (grading system IASP-NeupSIG) Patient has a score of 6 or higher on the Numeric Rating Scale (NRS) Subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits Exclusion Criteria: Subject diagnosed with a nociceptive chronic pain syndrome Subject does not agree to participate or is unlikely to participate for the entirety of the study Subject is currently participating in another clinical investigation with an active treatment arm

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exablate treatment<br>Exablate treatment on Neuropathic Pain | Device: Exablate treatment<br>* Exablate treatment for Neuropathic Pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numerical Rating Score (NRS) | The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | 72 h | 
| Pain Numerical Rating Score (NRS) | The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | 1 month | 
| Pain Numerical Rating Score (NRS) | The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | 3 months | 
| Pain Numerical Rating Score (NRS) | The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level. | 12 months |