BurstDR Stimulation for Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.

Official Title
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BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Combination Product: SCS in combination with CMM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS) HbA1c ≤10% BMI <45 kg/m2 Be 22 years of age or older at the time of enrollment Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English Be willing and capable of giving informed consent Be willing and able to comply with study-related requirements, procedures, and scheduled visits Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator Be on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator Exclusion Criteria: Current daily opioid dosage greater than 120 mg morphine equivalents Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome,Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury, as determined by the Investigator Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator Have prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain Be benefitting from an interventional procedure and/or surgery to treat lower limb pain (Subjects should be enrolled at least 30 days from last benefit). Have an existing intrathecal pain pump and/or another active implantable device such as a pacemaker Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual Have either a metastatic malignant neoplasm or untreated local malignant neoplasm Have a life expectancy of less than one year Have a local infection at the anticipated surgical entry site or an active systemic infection Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs Be concomitantly participating in another clinical study Be involved in an injury claim under current litigation Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain Have a pending or approved worker's compensation claim Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by a psychologist in the last 12 months

Ages Eligible for Study
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Minimum Age: 22 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PDN treated with SCS and CMM<br>Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care. | Combination Product: SCS in combination with CMM<br>* Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline to 3 months in treatment responder rates | Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm) | 0 no pain at all, 10 worse pain imaginable | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, spinal cord stimulation, burst stimulation