Spinal Cord Stimulation for Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Spinal Cord Stimulation (SCS) therapy in individuals who suffer from painful diabetic peripheral neuropathy. Patients invited to participate in this study will be eligible for SCS therapy, and will have already selected therapy with the Advanced Bionics Precision system independent of possible inclusion in this study. The device, accessories, and procedures associated with device placement and the indications for use are all consistent with the current and approved product labeling.

Detailed Description
-----------------
The management of neuropathic pain is often difficult, and the available treatment options rarely provide complete relief. Although prevention by means of glycemic control is the first priority, up to 20% of patients will develop Diabetic Peripheral Neuropathy (DPN) and require active drug therapy. Select anti-depressants, anti-epileptics, and opioids have generally been the first-line pharmacologic treatments for neuropathic pain. Topical creams have been used to achieve local control. Nonconventional therapies have included acupuncture and magnet therapy. However, all of these treatments have limited utility because of marginal efficacy. Various forms of electric stimulation have been shown to improve the symptoms of DPN. Advances in spinal cord stimulation technology have encouraged broader use of this treatment modality in the management of chronic painful DPN.

Official Title
-----------------
Precision Spinal Cord Stimulation for Painful Diabetic Neuropathy

Conditions
-----------------
Diabetic Neuropathy, Pain, Peripheral Neuropathy

Intervention / Treatment
-----------------
* Device: Precision Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have chronic neuropathic pain in at least one limb with a score of at least 3 using the Michigan Neuropathy Screening Instrument (MNSI) secondary to Type 1 or Type 2 diabetes Have chronic neuropathic pain for at least 12 months Be 18 years of age or older Be refractory to pain medication including gabapentin or the use of pain medication is contraindicated or not tolerated because of side effects or other medical condition Be an appropriate candidate for SCS therapy and have already decided to use the Precision system Be willing and able to comply with all study related procedures and visits Be capable of reading and understanding patient information materials and giving written informed consent Exclusion Criteria: Are a smoker Have any other chronic pain condition likely to confound evaluation of study endpoints Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints such as peripheral vascular disease or neurological disorders unrelated to diabetic neuropathy

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 |
| --- | --- |
| Other: Spinal Cord Stimulation Group<br>Spinal Cord Stimulation (SCS) Treatment Group | Device: Precision Spinal Cord Stimulation<br>* Stimulation on throughout the study once device is implanted<br>* Other names: Precision Spinal Cord Stimulation System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Rating at 6 Months Post Activation Compared to Baseline |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Implantable stimulation device, Neuropathy