Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy (PDN-SENSORY)

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    236
  • sponsor
    Nevro Corp
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Updated on 20 September 2023
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Summary

The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.

Details
Condition Painful Diabetic Neuropathy
Age 22years or above
Treatment 10 kHz SCS, CMM alone
Clinical Study IdentifierNCT05777317
SponsorNevro Corp
Last Modified on20 September 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs
Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits
Has PDN symptoms that have been present ≥12 months
Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects
Has been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2
Has painful diabetic sensorimotor polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) >5 at enrollment. The total score must include presence of foot pain (≥1) and sensory exam findings (≥ 2)
Has hemoglobin A1c ≤10% as measured at enrollment
Is 22 years of age or older at the time of enrollment
Is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician
Is willing to and capable of giving written informed consent
Is willing and able to comply with study-related requirements and procedures and attend all scheduled visits

Exclusion Criteria

Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs
Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment
Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months
Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure
Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure
Is currently prescribed a daily opioid dosage > 120 mg morphine equivalents
Has a medical condition or diagnosis that is inconsistent with the Senza System guidelines in the Physician's Manual or as per standard clinical practice
Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, critical limb ischemia due to peripheral vascular disease or small vessel disease)
Has prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain
Has an existing drug pump and/or another active implantable device such as a pacemaker (ok to have an insulin pump or continuous glucose monitor that remains externalized)
Has a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza System guidelines in the Physician's Manual
Has a life expectancy of less than one year
Has a local infection at the anticipated surgical entry site or an active systemic infection
Is pregnant or plans to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control)
Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs
Is concomitantly participating in another interventional clinical study
Is involved in an injury claim for study-related chronic pain that is under current litigation
Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain
Has a pending or approved worker's compensation claim for study-related chronic pain
Has 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 the investigator in the last 12 months
Has a BMI > 45 at enrollment
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