Spinal Cord Stimulation for Diabetic Neuropathy

Overseen By Julia T Hoffman, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Antithrombotics

Disqualifiers: Psychiatric disorder, Non-healing wounds, others

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

Compensation: Varies

Number of Visits: 3

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests spinal cord stimulation (SCS) to determine if it can relieve leg pain caused by peripheral arterial disease (PAD) and diabetic neuropathy. The goal is to assess whether this treatment can improve blood flow and reduce pain during walking or exercise, which is often difficult for individuals with these conditions. Participants will alternate between receiving active stimulation and a sham (fake) treatment to compare effects. The study seeks individuals with diabetes who have experienced PAD-related leg pain for at least three months and have previously tried a spinal cord stimulator with some success. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for managing leg pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to hold antithrombotic therapy (medications that prevent blood clots) according to specific guidelines.

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

Research has shown that spinal cord stimulation (SCS) is generally safe and effective for treating certain types of pain. Studies have found that high-frequency SCS can significantly reduce pain, with many patients experiencing substantial relief. In one study, 83% of participants achieved successful pain relief with high-frequency SCS, and only one person withdrew early.

High-frequency SCS is also associated with a lower risk of serious health issues, such as heart problems, major amputations, and infections in individuals with painful diabetic nerve damage. This indicates that the treatment is not only effective but also safe for long-term use.

While SCS is approved for treating painful diabetic nerve damage, it is important to note that it has not been specifically tested for pain resulting from poor blood flow in the legs. However, current research on its safety and effectiveness in similar conditions is promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetic neuropathy, which often involve medications like pain relievers or antidepressants to manage symptoms, spinal cord stimulation (SCS) offers a novel approach by directly targeting the nervous system. Researchers are excited about SCS because it uses electrical impulses to modulate nerve activity, potentially providing more effective and longer-lasting pain relief without the side effects associated with drugs. Additionally, this approach may help improve quality of life by reducing the dependence on medication and, by extension, the risk of medication-related complications.

What evidence suggests that spinal cord stimulation might be an effective treatment for claudication pain from PAD?

Research shows that spinal cord stimulation (SCS), which participants in this trial may receive, effectively treats painful diabetic nerve damage. Studies have found that high-frequency SCS, particularly at 10 kHz, significantly reduces pain for more than half of the patients with this condition. In many cases, pain decreased by over 30%, marking a significant improvement. Although SCS is approved for diabetic nerve pain, it hasn't been specifically tested for leg pain caused by poor blood flow in people with PAD. However, the positive results in diabetic nerve pain suggest it might also help with leg pain in PAD patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Peter Pellegrino, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults aged 19-90 with Type 2 Diabetes who suffer from painful diabetic neuropathy and peripheral arterial disease. They must have significant pain from neuropathy and walking, confirmed PAD via tests, a low quality of life score related to vascular issues, and be suitable candidates for spinal cord stimulation therapy.

Inclusion Criteria

I am between 19 and 89 years old and have diabetes.

I am a suitable candidate for a spinal cord stimulator implant.

I experience nerve pain with a severity of at least 5 out of 10.

Exclusion Criteria

My spine is unstable, as shown by specific spine X-rays.

I have wounds that are not healing.

My walking is impaired for reasons not related to peripheral artery disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SCS Implantation and Optimization

Participants undergo permanent spinal cord stimulator implantation and optimization

12 weeks

1 visit (in-person)

Intervention

Participants receive two weeks of active spinal cord stimulation and two weeks of sham intervention in a cross-over design

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham stimulation
• Spinal cord stimulation

Trial Overview

The study compares the effects of actual spinal cord stimulation (SCS) versus sham (fake) stimulation in managing pain due to diabetic neuropathy and poor blood flow in limbs. Participants will undergo SCS placement, followed by two weeks each of real and sham stimulations in random order over four weeks.

How Is the Trial Designed?

Group I: Active Spinal Cord Stimulation Experimental Treatment 1 Intervention

Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.

Group II: Sham Stimulation Placebo Group 1 Intervention

Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Nevro Corp

Industry 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 study of 11 diabetic patients with chronic lower limb pain who did not respond to conventional treatments, spinal cord stimulation (SCS) provided significant pain relief, with average pain scores dropping from 77 to 34 over 6 months.

Eight out of nine patients continued to experience substantial pain relief at the end of the study, allowing many to reduce their pain medication, indicating that SCS is an effective and safe therapy for chronic diabetic neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. de Vos, CC., Rajan, V., Steenbergen, W., et al.[2011]

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 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/38245324/

Spinal cord stimulation in painful diabetic neuropathy

As was shown in a randomized controlled trial, SENZA-PDN (NCT03228420), 10 kHz SCS is safe and effective for the treatment of painful diabetic neuropathy.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168822723005235

Spinal cord stimulation in painful diabetic neuropathy

15. Conclusions. 10 kHz SCS has been demonstrated to be safe and effective for the treatment of painful diabetic neuropathy. For a group of patients for whom ...

3.

neuromodulationjournal.org

neuromodulationjournal.org/article/S1094-7159(22)01403-9/fulltext

Long-Term Evaluation of Spinal Cord Stimulation in ...

Moreover, for > 50% of patients, the pain reduction was > 30%, which is considered clinically meaningful. No differences were found regarding ...

4.

jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2777806

Effect of High-frequency (10-kHz) Spinal Cord Stimulation ...

This randomized clinical trial evaluates whether 10-kHz spinal cord stimulation improves outcomes for patients with painful diabetic neuropathy

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37833046/

Quantitative assessment of painful diabetic peripheral ...

Preliminary data suggested that treatment of PDN with high-frequency SCS resulted in improvements on neurological examination. The purpose of ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P010032S189B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic. Peripheral Neuropathy: Five-Year Follow-up of a ...

7.

pubmed.ncbi.nlm.nih.gov

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

Long-term efficacy of high-frequency (10 kHz) spinal cord ...

Results: At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S016882272300517X

Real world outcomes with spinal cord stimulation

Among patients enrolled in this trial 83% achieved successful pain relief when treated with high frequency SCS, with one patient dropping out of the study due ...

9.

thelancet.com

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

Spinal cord stimulation for the treatment of painful diabetic ...

Our results suggest that SCS treatment of PDN is associated with a reduced risk of MACE, all-cause mortality, major amputation, suicide, and staphylococcus ...