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

Trial Summary

What is the purpose of this trial?

The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.

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 data supports the effectiveness of the treatment Spinal Cord Stimulator (SCS) for diabetic neuropathy?

Research shows that high-frequency spinal cord stimulation (HF10 therapy) is effective in reducing pain for people with diabetic neuropathy, with benefits lasting up to 24 months. It has also been shown to improve the quality of life for patients with this condition. ^{1 2 3 4 5}

Is the Spinal Cord Stimulator (SCS) safe for humans?

The high-frequency spinal cord stimulator (HF10 SCS) has a safety profile equivalent to traditional spinal cord stimulation, meaning it is generally considered safe for humans. It has been used widely in the USA, Europe, and Australia for treating chronic pain conditions. ^{1 2 6 7 8}

How is the Spinal Cord Stimulator treatment different for diabetic neuropathy?

The Spinal Cord Stimulator (SCS) treatment for diabetic neuropathy uses high-frequency (10 kHz) stimulation, which is unique because it does not cause tingling sensations (paresthesia) and has shown superior long-term effects compared to traditional low-frequency SCS. This approach improves the patient's experience during the procedure and has been effective in managing chronic pain associated with diabetic neuropathy. ^{1 3 4 5 9}

Research Team

David Caraway, MD

Principal Investigator

Chief Medical Officer, Nevro Corp

Eligibility Criteria

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

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. [2019]

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. United States pubmed.ncbi.nlm.nih.gov

Clinical Effect Analysis of Spinal Cord Electrical Stimulator Implantation for Diabetic Foot. [2023]

5. 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]

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

10-kHz High-Frequency SCS Therapy: A Clinical Summary. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation for Complex Regional Pain Syndrome: A Case Report. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Network Meta-analysis of Neurostimulation for Painful Diabetic Neuropathy. [2023]