PNS Device for Chronic Pain

Overseen By Brendan Astley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Curonix LLC

Disqualifiers: Concurrent study enrollment, Other pain devices

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Freedom PNS System, a peripheral nerve stimulation device, for individuals with persistent pain unresponsive to standard treatments. Researchers will review records from 40 individuals who already have this device implanted to assess changes in their pain over at least a year. The trial targets those with chronic nerve-related pain who have not found relief with other treatments. Participants must have the device implanted and be willing to attend follow-up visits. As an unphased trial, this study provides an opportunity to contribute to understanding the long-term benefits of an innovative pain management device.

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 cannot participate if you are enrolled in another drug or device study.

What prior data suggests that the Freedom PNS System is safe for chronic pain patients?

Research has shown that the Freedom PNS System is safe and generally easy to use. Several studies have found it effective for chronic pain that does not improve with other treatments. One study focused on nerve pain in the legs reported no complications. Another study confirmed its safety and effectiveness in managing long-term pain. As a result, users of the Freedom PNS System typically do not experience serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Freedom PNS System is unique because it targets chronic pain through Peripheral Nerve Stimulation (PNS), offering a non-drug alternative that directly modulates nerve activity. Unlike standard treatments like opioids or NSAIDs, which can have significant side effects and dependencies, the Freedom PNS System provides pain relief by sending mild electrical pulses to nerves. Researchers are excited because this method could reduce reliance on medications, offering a safer and more sustainable pain management option.

What evidence suggests that the Freedom PNS System is effective for chronic pain?

Studies have shown that the Freedom PNS System effectively treats long-lasting pain. It significantly reduces pain levels and decreases the need for pain medications. Patients have experienced lasting pain relief for up to 24 months after using it. Research also indicates that people using this device enjoy a better quality of life. The Freedom PNS System is recognized for helping with pain that hasn't improved with other treatments. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic, intractable pain from peripheral nerve issues that haven't improved with standard treatments. Participants must have had the Freedom PNS System implanted for at least a year.

Inclusion Criteria

Subject has been implanted with the Freedom PNS system

I am willing to follow the study schedule and requirements.

I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective)

Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Chart Review

A retrospective chart review will be conducted to assess baseline parameters in patients who have received a permanent implant with the Freedom PNS system.

12 months

Prospective Follow-up

Participants are monitored for safety and effectiveness after receiving the implant, with data collected on pain scores, opioid use, work status, sleep, and quality of life.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Freedom PNS System

Trial Overview

The study looks back at medical records and follows up on patients who received the Freedom PNS device to manage chronic pain. It's observational, meaning no new treatment is given during the study.

How Is the Trial Designed?

Group I: Observational Experimental Treatment 1 Intervention

observational

Who Is Running the Clinical Trial?

Curonix LLC

Lead Sponsor

Trials

9

Recruited

680+

MetroHealth System, Ohio

Collaborator

Trials

8

Recruited

26,100+

Published Research Related to This Trial

Neuroprosthetic systems are being developed to assist severely disabled individuals, highlighting the importance of balancing their innovative benefits with potential risks.

The FDA is actively promoting a patient-centered approach in the development of these devices, emphasizing the need for patient input in assessing the benefits and risks throughout the product's life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetics and the science of patient input. Benz, HL., Civillico, EF.[2019]

From 2013 to 2016, the incidence of adverse events (AEs) in Swedish hospitals decreased from 13.1% to an average of 11.4%, indicating improvements in patient safety during this period.

Preventable AEs were significantly more common (84% more) in patients cared for in inappropriate units ('off-site'), highlighting the importance of proper patient placement and the substantial economic burden of these events, which accounted for 13%-14% of total hospital care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. Nilsson, L., Borgstedt-Risberg, M., Soop, M., et al.[2019]

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 2017 version of ISO 14708-3 introduces significant updates, including the recognition of non-electrode neurostimulators, which could enhance the safety and functionality of these devices.

New safety concerns are addressed for the first time, such as wireless charging temperature and MRI acceptance criteria, indicating a shift towards more comprehensive safety standards for implantable neurostimulators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interpretation of the International Standard 2017 Version of Implantable Neurostimulators]. Wang, W., Li, L., Li, Q., et al.[2018]

In the first 18 months after FDA approval of the Charité artificial disc, the reported rate of adverse events was relatively low, starting at 0.58% and peaking at 2.34%, indicating a manageable safety profile for this lumbar arthroplasty device.

The most common adverse event was anterior migration requiring reoperation (0.65%), but overall rates of adverse events were lower than those reported in the initial investigational studies, suggesting that the device's real-world performance may be better than initially anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first 18 months following food and drug administration approval of lumbar total disc replacement in the United States: reported adverse events outside an investigational device exemption study environment. Blumenthal, SL., Guyer, RD., Geisler, FH., et al.[2022]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

Peripheral nerve stimulation (PNS) has been effectively used for over 50 years to treat chronic pain in patients who have not responded to other treatments, but the technology has not significantly evolved during this time.

Current PNS devices, originally designed for spinal cord stimulation, have led to complications and hindered the broader adoption of PNS therapy, highlighting the need for technology specifically tailored for PNS applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology for Peripheral Nerve Stimulation. Parker, JL., Cameron, T.[2015]

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]

Spinal cord and peripheral nerve stimulation have been used since the 1960s to relieve chronic pain, showing a consistent 50% improvement in long-term pain control for patients who have not responded to other treatments.

Advancements in technology and better patient selection criteria have enhanced the effectiveness of these interventions, suggesting that even greater pain relief may be possible in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation: spinal cord and peripheral nerve stimulation. Day, M.[2019]

In a study involving 9 subjects, percutaneous peripheral nerve stimulation (PNS) led to significant pain relief, with 67% of participants experiencing at least a 50% reduction in pain intensity after one month of treatment, and many maintaining this relief for up to 12 months post-treatment.

The study found no serious adverse events, suggesting that PNS is a safe and effective alternative for managing chronic low back pain, potentially reducing the need for opioids and invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short-Term Implant. Gilmore, CA., Kapural, L., McGee, MJ., et al.[2020]

In a retrospective study of five patients with chronic neuropathic pain who received wireless percutaneous nerve stimulation (PNS), all patients experienced over 50% pain relief at three months, highlighting the potential efficacy of this minimally invasive technique.

While some patients were able to reduce their analgesic intake, sustained benefits were not observed after one year, indicating the need for further research to evaluate long-term outcomes and the effectiveness of wireless PNS compared to traditional spinal cord stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real world experience with minimally invasive wireless percutaneous neuromodulation in a tertiary care centre. Pushparaj, H., Chawla, R., Bhargava, D., et al.[2023]

Vagus nerve stimulation (VNS) and repetitive transcranial stimulation (rTMS) are both FDA-cleared treatments for resistant depression, but VNS devices are generally considered a contraindication for rTMS due to safety concerns.

Despite this contraindication, clinicians have reported using rTMS in patients with implanted VNS systems, suggesting that with proper precautions and consent procedures, rTMS can be safely administered, as VNS components are typically outside the electromagnetic field of rTMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe use of repetitive transcranial magnetic stimulation in patients with implanted vagus nerve stimulators. Philip, NS., Carpenter, SL., Carpenter, LL.[2021]

Peripheral nerve stimulation (PNS) is a safe and effective treatment for chronic pain, showing significant reductions in patient-reported pain scores from an average of around 7.4 to approximately 1.6 within the first month and sustained relief for up to 24 months across 57 patients.

Patients also experienced a notable decrease in their use of morphine, indicating that PNS not only alleviates pain but may also reduce reliance on opioid medications, with significant reductions observed at 6, 12, and 24 months post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Peripheral Nerve Stimulation with a High Frequency Electromagnetic Coupled (HF-EMC) Powered Implanted Receiver in Treating Different Pain Targets/Neuralgias. Abd-Elsayed, A., Moghim, R.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9969801/

Efficacy of Peripheral Nerve Stimulation with a High ...

PNS has been shown to be safe and effective in treating chronic pain at different sites with sustained pain relief for up to 24 months.

2.

curonix.com

curonix.com/news/

News & Clinical Evidence

Independent clinical study shows Curonix's Freedom® PNS System significantly reduces pain scores and medication usage.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03877653

NCT03877653 | Freedom-1 Study for Chronic Knee Pain

To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did ...

4.

wipmsoc.org

wipmsoc.org/pns-statement

PNS Statement

A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain, Pain Physician, May 2023.

5.

painmedicine-casereports.com

painmedicine-casereports.com/current/pdf?article=ODEx

peripheral nerve stimulation using

In conclusion, our study provides strong evidence for the efficacy of the Freedom PNS System in reducing pain and improving the quality of life ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K233162.pdf

June 20, 2024 Curonix Danielle Besal Principal Consultant ...

The Freedom PNS System is a single-use, prescription-only system, to be implanted by an appropriate clinician, such as a neurosurgeon, ...

7.

curonix.com

curonix.com/providers/peripheral-nerve-stimulation/

Peripheral Nerve Stimulation

The Freedom® Peripheral Nerve Stimulator (PNS) System is indicated for pain management in adults with severe, intractable chronic pain of peripheral nerve ...

8.

painphysicianjournal.com

painphysicianjournal.com/current/pdf?article=NzgzOQ%3D%3D&journal=161

Peripheral Nerve Stimulation Uses

PNS using the Curonix Freedom® PNS System is an effective and safe therapy for treating chronic lower extremity pain that resists conservative management.

9.

firstwordpharma.com

firstwordpharma.com/story/5918799

Curonix Foundational Clinical Data Published Within the ...

These long-term studies further substantiate that the Freedom PNS System is a safe and effective treatment option for chronic pain management.

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38805528/

Peripheral Nerve Stimulation Uses High-Frequency ...

No complications were reported. Conclusion: PNS done with the Curonix Freedom® PNS System is an effective and safe therapy for lower-extremity neuralgias.