Electrical Stimulation for Peripheral Neuropathy

(SELECT Trial)

Recruiting at 2 trial locations

Overseen By Katelyn So, MHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Epineuron Technologies Inc.

Disqualifiers: Peripheral neuropathy, Active implanted device

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electrical stimulation system, the Temporary Peripheral Nerve Stimulation System, to determine its effectiveness for people with ulnar neuropathy at the elbow. This condition affects the nerves and causes pain or tingling. Researchers aim to discover if adding this electrical stimulation to standard care can improve symptoms. Participants will receive either standard care alone or standard care plus a one-hour session of electrical stimulation. Those with ulnar neuropathy (nerve issues in the elbow) and no other nerve problems or implanted devices might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for ulnar neuropathy.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this nerve stimulation system is safe for peripheral neuropathy?

Research has shown that peripheral nerve stimulation (PNS) treatments are generally safe for people with long-term pain. Studies have found that PNS can reduce pain levels in patients with various types of nerve pain. One study using the SPRINT® PNS system, similar to the one tested in this trial, received FDA approval for treating certain pain conditions, indicating likely safety.

Most patients in these studies reported less pain without serious side effects. However, some might experience mild discomfort or tingling where the stimulation is applied. Overall, many who have tried the treatment find it tolerable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it offers a unique approach to managing peripheral neuropathy with electrical stimulation. Unlike standard treatments that often involve medications like pain relievers or antidepressants, this method uses a temporary peripheral nerve stimulation system to provide a single, one-hour dose of electrical stimulation. This innovative technique could potentially offer relief without the side effects associated with drugs and might show faster results. The focus on electrical stimulation also opens up new possibilities for understanding how nerve signals can be modulated to alleviate discomfort, providing a fresh perspective on managing this condition.

What evidence suggests that this electrical stimulation system is effective for peripheral neuropathy?

Research has shown that temporary peripheral nerve stimulation (PNS) can significantly reduce pain in individuals with nerve-related conditions. One study demonstrated that a 60-day PNS treatment lowered pain levels and improved daily activities for patients. Real-world evidence supports these findings, showing ongoing improvements in pain and function after PNS treatment. This trial will evaluate the effectiveness of a single, 1-hour dose of electrical stimulation as part of the experimental intervention arm, compared to standard care alone in the control arm. The FDA has already approved this therapy for some types of long-term pain, confirming its effectiveness. Overall, the data suggest that PNS could be a valuable option for managing nerve-related pain. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with ulnar neuropathy at the elbow, which is a condition affecting the nerve on the inner side of the elbow. It's not suitable for people who have an active implanted device or peripheral neuropathy that affects nerves other than the one of interest.

Inclusion Criteria

I have nerve damage in my elbow.

Exclusion Criteria

Patients with any active implanted device

I have nerve damage not related to the nerve being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care plus a single, 1-hour dose of electrical stimulation

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment, including sensory recovery and functional recovery assessments

1.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Temporary Peripheral Nerve Stimulation System

Trial Overview The study is testing a new temporary nerve stimulation system designed to be used after surgery for cubital tunnel syndrome. The goal is to see if this electrical stimulation can help improve recovery outcomes.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Standard of care only.

Group II: Experimental Intervention Active Control 1 Intervention

Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.

Who Is Running the Clinical Trial?

Epineuron Technologies Inc.

Lead Sponsor

Trials

3

Recruited

160+

Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

Collaborator

Trials

4

Recruited

590+

Published Research Related to This Trial

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

In a retrospective case series involving 8 patients with neuropathic extremity pain, 75% of the trials for peripheral nerve stimulation (PNS) were successful, leading to permanent implantation of the PNS system.

The minimally invasive, ultrasound-assisted technique resulted in over 50% pain relief for most patients at follow-up, with some experiencing over 80% relief, demonstrating both efficacy and safety by avoiding the complications associated with traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided permanent implantation of peripheral nerve stimulation (PNS) system for neuropathic pain of the extremities: original cases and outcomes. Huntoon, MA., Burgher, AH.[2022]

In a study of 12 patients with peripheral neuropathic pain (PNP), short-term peripheral nerve stimulation (PNS) significantly reduced pain levels by an average of 85.5% after six treatments, indicating strong efficacy for managing PNP symptoms.

The PNS procedure was found to be safe, with no serious adverse events reported, suggesting it could be a viable treatment option for individuals suffering from PNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the posterior tibial nerve reduces neuropathic pain in patients with polyneuropathy. Dabby, R., Sadeh, M., Goldberg, I., et al.[2023]

Ultrasound-guided placement of peripheral nerve stimulation (PNS) electrodes is feasible and can be done accurately at specific locations near the tibial, peroneal, and sciatic nerves, as demonstrated in a study using four cadaver specimens.

No visible neural injuries occurred during the electrode placement, suggesting that this minimally invasive technique may be a safe alternative to traditional open surgical methods for managing lower extremity neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes in a cadaver model: part one, lower extremity. Huntoon, MA., Huntoon, EA., Obray, JB., et al.[2019]

A pilot study involving patients with painful diabetic neuropathy showed that pulsed-dose electrical stimulation significantly reduced pain levels over a 4-week treatment period, as measured by a visual analog scale.

This study is the first to report on the use of a knitted silver-plated stocking electrode for delivering electrical stimulation, suggesting it may be an effective method for alleviating burning pain in diabetic neuropathy patients with intact protective sensation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? Armstrong, DG., Lavery, LA., Fleischli, JG., et al.[2019]

A new training curriculum for Peripheral Nerve Stimulation (PNS) has been developed by a multidisciplinary task force to standardize education and improve proficiency in this effective treatment for chronic pain.

The curriculum includes defined milestones for learners at different levels (early, advanced, and practitioner) and covers essential skills such as professionalism, medical knowledge, and procedural skills, ensuring comprehensive training in PNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

Peripheral nerve stimulation (PNS) is an advanced treatment option for patients with peripheral neuropathic pain, particularly when other treatments have failed, highlighting its role as a specialized analgesic technique.

In a reported case of intractable neuropathic pain after multiple surgeries, PNS provided significant pain relief after previous treatments were ineffective, demonstrating its efficacy in managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation in intractable neuropathic pain. Kozak, J., Kobesova, A., Vrba, I., et al.[2013]

The Nalu™ Neurostimulation System represents a significant advancement in peripheral nerve stimulation for chronic neuropathic pain, transitioning from invasive surgeries to minimally invasive procedures.

This device has shown effectiveness in managing various chronic pain conditions, including post-herniorrhaphy pain syndrome and complex regional pain syndrome, indicating its potential as a reliable treatment option for peripheral neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. Kalia, H., Pritzlaff, S., Li, AH., et al.[2022]

The StimRouter® system is a minimally invasive, FDA-approved treatment for peripheral mononeuropathy that has shown a high margin of safety in multiple clinical trials, making it safer than other systems that require more invasive surgical procedures.

Clinical studies indicate that the StimRouter system effectively reduces pain and improves activity levels and quality of life for patients suffering from chronic peripheral mononeuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the StimRouter® peripheral neuromodulation system for chronic pain management. Regnier, SM., Chen, J., Gabriel, RA., et al.[2021]

In a retrospective study of 46 patients with painful nerve injuries, peripheral nerve stimulation (PNS) provided good pain relief (50% or more reduction) in 78% of cases over a follow-up period of 3 to 16 years.

The average pain intensity significantly decreased from a visual analog scale (VAS) score of 69 before surgery to 24 after PNS, indicating that PNS is an effective long-term treatment option for selected patients with isolated painful neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37192232/

A Retrospective Review of Real-world Outcomes Following ... This retrospective analysis supports recent prospective studies demonstrating that 60-day percutaneous PNS can provide significant relief across a wide range ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616055/

Temporary Peripheral Nerve Stimulation as Treatment for ... This study demonstrated the potential role for PNS therapy in improving patient-reported pain levels for various neuropathies, targeting various nerves.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07166952

Peripheral Nerve Stimulation With the SPRINT® System in ... The aim of this study is to understand whether the FDA-cleared SPRINT PNS system is safe and effective for the treatment of chronic PSIJC pain.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000699

Durable patient-reported outcomes following 60-day ... Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain ...

5. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2022-0005

Real-World Evidence of Sustained Improvement Following ... This study presents real-world data from a cross-sectional follow-up survey of patients who previously received 60-day peripheral nerve stimulation (PNS) ...