10 kHz Spinal Cord Stimulation for Diabetic Neuropathy
(PDN-SENSORY Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nevro Corp

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 22 with chronic lower limb pain from diabetic neuropathy, who've had stable pain medication use and a hemoglobin A1c ≤10%. They should have tried multiple pain relief methods without success. Exclusions include severe cardiovascular issues, high opioid use, certain psychological conditions, BMI >45, or other conflicting medical devices or conditions.

Inclusion Criteria

My leg pain has been 5 or more out of 10 for the past week.

My doctor agrees I can safely undergo the surgeries needed for this study.

I am willing and able to sign a consent form.

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Exclusion Criteria

You are not expected to live for more than a year.

Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.

You are receiving temporary Social Security Disability Insurance (SSDI) benefits because of ongoing pain related to the study.

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Treatment Details

Interventions

10 kHz SCS (Spinal Cord Stimulation)

Trial OverviewThe study tests if a high-frequency spinal cord stimulation (SCS) at 10 kHz plus conventional medical management (CMM) can better manage pain and improve neurological function in patients with painful diabetic neuropathy compared to CMM alone. Participants are randomly assigned to one of the two groups.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: 10 kHz SCS plus CMMExperimental Treatment1 Intervention

Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM)

Group II: CMM aloneActive Control1 Intervention

Treatment with conventional medical management (CMM) alone