10 kHz Spinal Cord Stimulation for Diabetic Neuropathy

(PDN-SENSORY Trial)

Recruiting at 1 trial location

Overseen By Don Middlebrook

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nevro Corp

Must be taking: Gabapentinoids, Analgesics

Must not be taking: Anticoagulants, Antiplatelets, Opioids

Disqualifiers: Mononeuropathy, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

143 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on a stable pain medication regimen for at least 30 days before joining the study.

What data supports the effectiveness of the 10 kHz Spinal Cord Stimulation treatment for diabetic neuropathy?

Research shows that 10 kHz spinal cord stimulation (SCS) provides significant pain relief and improves quality of life for patients with painful diabetic neuropathy. Studies found that patients experienced greater pain reduction with 10 kHz SCS compared to traditional low-frequency SCS, with an average pain reduction of 73.7%. ^{1 2 3 4 5}

Is 10 kHz spinal cord stimulation safe for humans?

Research shows that 10 kHz spinal cord stimulation is generally safe for treating painful diabetic neuropathy, with no worsening of neurological deficits reported and some improvements in sensory function and reflexes. ^{1 3 4 5 6}

How is 10 kHz spinal cord stimulation different from other treatments for diabetic neuropathy?

10 kHz spinal cord stimulation is unique because it uses high-frequency electrical impulses to relieve pain and improve nerve function in diabetic neuropathy, unlike traditional treatments that often rely on medications. This method has shown promising results in providing long-term pain relief and improving quality of life for patients with this condition. ^{1 3 4 5 6}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conventional medical management (CMM) or 10 kHz spinal cord stimulation (SCS) plus CMM

6 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• 10 kHz SCS

Trial Overview The 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

Group I: 10 kHz SCS plus CMM Experimental Treatment 1 Intervention

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

Group II: CMM alone Active Control 1 Intervention

Treatment with conventional medical management (CMM) alone

Who Is Running the Clinical Trial?

Nevro Corp

Lead Sponsor

Trials

11

Recruited

1,800+

Findings from Research

In a study of 216 patients with refractory painful diabetic neuropathy, 10 kHz spinal cord stimulation (SCS) led to a remarkable 79.9% reduction in pain over 24 months, with 90.1% of participants achieving at least 50% pain relief.

The treatment also significantly improved health-related quality of life and sleep, with 65.7% of participants showing clinically meaningful neurological improvements, indicating that 10 kHz SCS is both safe and effective for long-term management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

In a multicenter randomized controlled trial involving 216 participants with refractory painful diabetic neuropathy, 10-kHz spinal cord stimulation (SCS) combined with conventional medical management led to a significant mean pain relief of 74.3% after 12 months, with 85% of participants experiencing at least 50% pain relief.

The treatment also resulted in substantial improvements in health-related quality of life, with 92% of participants reporting satisfaction with the 10-kHz SCS, indicating its effectiveness and durability as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation (10 kHz) alters sensory function and nerve fiber density in painful diabetic neuropathy: a pilot prospective open-label study. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Low-Intensity 10 kHz Spinal Cord Stimulation Reduces Behavioral and Neural Hypersensitivity in a Rat Model of Painful Diabetic Neuropathy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

10-kHz spinal cord stimulation treatment for painful diabetic neuropathy: results from post-hoc analysis of the SENZA-PPN study. [2021]