10 kHz Spinal Cord Stimulation for Diabetic Neuropathy

(PDN-SENSORY Trial)

Not currently recruiting at 1 trial location

Overseen By Daniel Bintrim, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treat painful diabetic neuropathy (PDN), which causes chronic leg pain due to diabetes. Researchers are testing a therapy that uses high-frequency spinal cord stimulation (SCS) to determine if it can better manage pain and improve nerve function compared to standard treatments. Participants will either continue with their usual care or receive this new 10 kHz SCS therapy in addition to their current treatment. Individuals who have experienced PDN symptoms for over a year and have found pain medications ineffective might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to better treatment options for PDN.

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 prior data suggests that this spinal cord stimulation is safe for diabetic neuropathy?

Earlier studies have shown promising safety results for 10 kHz spinal cord stimulation (SCS). Research indicates that this treatment can significantly reduce pain for people with painful diabetic neuropathy (PDN) without causing uncomfortable sensations like tingling. Over 24 months, many participants experienced a significant drop in pain levels, and most did not encounter any serious side effects.

Additional evidence suggests that 10 kHz SCS might even lower the risk of serious health problems such as heart attacks, major amputations, and infections. These findings suggest that high-frequency SCS is well-tolerated and safe for managing PDN. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for diabetic neuropathy, which typically involves medications like pain relievers and antidepressants, 10 kHz spinal cord stimulation (SCS) offers a novel approach by directly targeting the spinal cord with high-frequency electrical pulses. This method aims to modulate pain signals before they reach the brain, potentially providing more effective relief for those who haven't found success with conventional treatments. Researchers are excited about this treatment because it not only promises to reduce pain with fewer side effects but also offers hope for improved quality of life in individuals suffering from chronic diabetic neuropathy.

What evidence suggests that this trial's treatments could be effective for painful diabetic neuropathy?

Research has shown that a treatment called 10 kHz spinal cord stimulation (SCS) can relieve pain from diabetic nerve damage, known as painful diabetic neuropathy (PDN). One study found that 79% of patients felt much better after using this treatment. Another study showed that patients continued to experience less pain and improved sleep for up to two years. Real-world data also supports that 10 kHz SCS provides significant pain relief for many who haven't found relief with other treatments. In this trial, participants will receive either 10 kHz SCS in addition to conventional medical management (CMM) or CMM alone. Overall, evidence suggests that 10 kHz SCS could be a promising way to manage pain in PDN. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37536514/

Long-term efficacy of high-frequency (10 kHz) spinal cord ... Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated ...

2. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2777806

Effect of High-frequency (10-kHz) Spinal Cord Stimulation ... In this randomized clinical trial including 216 patients, there was a significant benefit of 10-kHz spinal cord stimulation, with 79% of treatment responders.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723006289

Long-term efficacy of high-frequency (10 kHz) spinal cord ... Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8861794/

A Real-World Analysis of High-Frequency 10 kHz Spinal ... This real-world study in typical clinical practices found 10 kHz SCS provided meaningful pain relief for a substantial proportion of patients refractory to ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00422-5/fulltext

Spinal cord stimulation for the treatment of painful diabetic ... In conclusion, we have demonstrated the impact of SCS on a variety of important long-term health outcomes when treating painful diabetic neuropathy including ...

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1611970/full

10 kHz spinal cord stimulation vs. traditional low-frequency ... This study seeks to provide robust evidence on the superiority of HF-SCS in pain relief, functional improvement, and microcirculatory benefits.