Spinal Cord Stimulator for Diabetic Neuropathy

(PDN-PM Trial)

Recruiting at 10 trial locations

Overseen By Kerry Bradley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nevro Corp

Disqualifiers: Mononeuropathy, Amputation, Large ulcers, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

497 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a Spinal Cord Stimulator (SCS) for individuals with severe leg pain from diabetic nerve damage, known as painful diabetic neuropathy (PDN). It aims to assess patient experiences with this therapy in real-world settings. The study seeks participants with diabetes who have been diagnosed with painful nerve issues in their lower legs and have not responded well to standard treatments. Participants will use a device that sends electrical pulses to the spine to help relieve pain. As an unphased trial, this study offers a unique opportunity to explore new pain relief options in a real-world setting.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that the Spinal Cord Stimulator (SCS) is generally safe for managing long-term pain. The FDA has approved this device for treating chronic pain in areas like the back, arms, and legs.

Studies have found that high-frequency SCS therapy, such as the 10 kHz therapy used by Nevro, is effective and well-tolerated by patients. Most people using it experience long-lasting pain relief without serious problems. Safety data indicates that its risks are similar to those of other spinal cord stimulators, with common side effects that are usually mild and manageable.

In summary, for those considering joining a trial for this treatment, existing research supports its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic neuropathy, which often include medications like gabapentin or duloxetine, the Spinal Cord Stimulator (SCS) offers a unique approach by directly modulating nerve signals to alleviate pain. Researchers are excited about this treatment because it targets pain relief at the source, potentially offering significant relief for patients who don't respond well to traditional medications. Additionally, SCS may provide faster and more sustained pain relief without the systemic side effects typically associated with oral medications.

What evidence suggests that the Spinal Cord Stimulator is effective for diabetic neuropathy?

Research has shown that Nevro's Spinal Cord Stimulation (SCS) therapy reduces pain in individuals with painful diabetic neuropathy (PDN). One study found that patients using the high-frequency 10 kHz SCS therapy experienced significantly less pain, with some reporting over a 50% reduction. This therapy also improved their quality of life and sleep over 24 months. Additionally, it proved more effective than traditional low-frequency spinal cord stimulation. These findings support the use of SCS to manage chronic pain in PDN. ^{1 2 4 6 7}

Who Is on the Research Team?

David Caraway, MD

Principal Investigator

Chief Medical Officer, Nevro Corp

Are You a Good Fit for This Trial?

This trial is for individuals with chronic leg pain due to painful diabetic neuropathy (PDN) who haven't found relief through standard treatments. Participants must have a consistent pain intensity of ≥5 out of 10 on the Visual Analog Scale, be diagnosed with diabetes per local guidelines, and be able to give informed consent and follow study procedures.

Inclusion Criteria

I have diabetes and experience severe leg pain due to nerve damage that hasn’t improved with standard treatments.

I am approved for Nevro Spinal Cord Stimulation treatment before joining the study.

I am approved for Nevro Spinal Cord Stimulation treatment.

Exclusion Criteria

Patients must not have a medical condition or diagnosis that is inconsistent with Nevro's SCS System guidelines in the Physician's Manual for the relevant country, or as per standard clinical practice

Patients must not have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the Investigator

I do not have nerve damage, major amputations, or large ulcers on my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Phase

Participants undergo a trial phase to assess pain relief, requiring at least 50% reduction in pain for success

2 weeks

Treatment

Participants receive Spinal Cord Stimulation therapy and are monitored for pain relief and device safety

12 months

Regular visits for assessments at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulator (SCS)

Trial Overview The study is observing the effectiveness of Nevro's Spinal Cord Stimulation (SCS) therapy at a frequency of 10 kHz in patients suffering from PDN. It's an observational global study that involves interdisciplinary treatment by pairing diabetes management teams with pain physicians.

How Is the Trial Designed?

Group I: IPG Activated Experimental Treatment 1 Intervention

The group of participants who have had a successful trial (\>50% pain relief) during the trial phase

Spinal Cord Stimulator (SCS) is already approved in United States, European Union for the following indications:

Approved in United States as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Approved in European Union as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Who Is Running the Clinical Trial?

Nevro Corp

Lead Sponsor

Trials

11

Recruited

1,800+

Published Research Related to This Trial

The HF10 spinal cord stimulator (SCS) is as effective as traditional low-frequency SCS for treating back and leg pain, with some studies indicating it may provide superior long-term relief.

The HF10 SCS system has a comparable safety profile to traditional SCS and simplifies the implantation process by eliminating the need for intraoperative paresthesia mapping, enhancing patient experience and reducing surgery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Senza System: a novel, high frequency 10 kHz (HF10), paresthesia free spinal cord stimulator. Ghosh, PE., Simopolous, TT.[2020]

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 study of 256 patients with chronic intractable pain, 73% reported successful trials with high frequency spinal cord stimulation (HF10 therapy), particularly those with back and leg pain, showing its effectiveness as a treatment option.

Patients experienced a sustained mean pain reduction of 50% up to 6 months post-implant, with significant improvements in functional outcomes, making HF10 a promising alternative to traditional spinal cord stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. Russo, M., Verrills, P., Mitchell, B., et al.[2019]

In a study of 19 patients with diabetic foot, spinal cord electrical stimulator implantation significantly reduced pain levels and improved quality of life, as indicated by lower visual analog scale scores and higher QOL scores post-surgery.

The procedure also enhanced nerve conduction velocities and increased blood flow to the lower limbs, achieving a high limb salvage rate of 94.74%, suggesting it is an effective treatment option for preventing toe amputation in diabetic foot patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. Zhou, PB., Bao, M.[2023]

HF10 spinal cord stimulation (SCS) therapy provides effective pain relief for chronic back and leg pain without causing paresthesia, making it a unique option for patients.

Clinical trials and reports indicate that HF10 SCS is safe and effective, even for patients who have not found relief with other neuromodulation therapies, suggesting it could be an important early treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10-kHz High-Frequency SCS Therapy: A Clinical Summary. Russo, M., Van Buyten, JP.[2022]

In a real-world study of 1660 patients with chronic trunk and/or limb pain, over 70% experienced at least 50% pain relief after high-frequency spinal cord stimulation (HF-SCS) at 10 kHz, demonstrating sustained efficacy over 12 months.

Patients also reported significant improvements in function (72.3%), sleep (68.0%), and quality of life (90.3%), with 32% reducing their medication intake, supporting HF-SCS as a beneficial treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. Stauss, T., El Majdoub, F., Sayed, D., et al.[2020]

Spinal cord stimulation (SCS) significantly reduces pain intensity in patients with painful diabetic neuropathy (PDN), with high-frequency SCS (HF-SCS) showing greater pain relief compared to low-frequency SCS (LF-SCS) and conventional medical management (CMM).

Both LF-SCS and HF-SCS improve health-related quality of life (HRQoL) for PDN patients, but the exact comparative benefits of HF-SCS over LF-SCS remain unclear due to a lack of direct head-to-head trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Network Meta-analysis of Neurostimulation for Painful Diabetic Neuropathy. Duarte, RV., Nevitt, S., Copley, S., et al.[2023]

The Nevro Senza 10-kHz high frequency spinal cord stimulation (HF10) therapy has shown significant promise for treating complex regional pain syndrome (CRPS), providing over 75% pain relief in a case study of a 53-year-old woman after 7 years of suffering.

Unlike traditional low-frequency spinal cord stimulation, HF10 therapy offers pain relief without causing the tingling sensations (paresthesia) that many patients experience, making it a potentially more comfortable option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation for Complex Regional Pain Syndrome: A Case Report. Crapanzano, JT., Harrison-Bernard, LM., Jones, MR., et al.[2018]

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

A Real-World Analysis of High-Frequency 10 kHz Spinal ... This retrospective, multi-center, real-world review assessed pain relief and functional improvements for consecutive patients with diabetic neuropathy aged ≥18 ...

2. nevro.com nevro.com/en/outcomes/

Outcomes - International English - Nevro Novel 10 kHz High-frequency Therapy (hf10 Therapy) Is Superior To Traditional Low-frequency Spinal Cord Stimulation For The Treatment Of Chronic Back And Leg ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130022S039B.pdf

P130022S039 Summary of Safety and Effectivness (SSED) The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs, ...

4. intl.nevro.com intl.nevro.com/English/us/investors/investor-news/investor-news-details/2023/New-24-Month-Data-Shows-Nevros-SCS-Therapy-Provides-Highly-Effective-Long-Term-Relief-from-Painful-Diabetic-Neuropathy/default.aspx

New 24-Month Data Shows Nevro's SCS Therapy Provides ... Evidence Published in Diabetes Research and Clinical Practice Shows 10 kHz Therapy Yields Lasting Pain Relief and Enhances Health-Related ...

5. 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 ...

6. nevrohfx.com nevrohfx.com/resources/safety-information/

Important safety information - Nevro HFX The safety of HFX has been thoroughly studied and proven. HFX has a similar safety profile, including side effects and risks, to other spinal cord stimulation ...

7. prnewswire.com prnewswire.com/news-releases/new-data-demonstrates-long-term-improvements-in-pain-intensity-with-nevros-high-frequency-spinal-cord-stimulation-therapy-302290662.html

New Data Demonstrates Long-Term Improvements in Pain ... Analysis Marks the First Study of Spinal Cord Stimulation to Demonstrate Long-term, Significant, and Clinically Meaningful Reductions in ...