PNS Device for Chronic Pain

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

Trial Summary

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 data supports the effectiveness of the Freedom PNS System treatment for chronic pain?

Research shows that peripheral nerve stimulation (PNS) is effective and safe for treating chronic pain, offering long-term relief and reducing the need for opioids. Studies have documented significant pain reduction in patients using PNS, highlighting its benefits over more invasive treatments. ^{1 2 3 4 5}

Is the PNS Device for Chronic Pain generally safe for humans?

The safety of neurostimulators, like the PNS Device, is guided by international standards that address concerns such as wireless charging temperature and electromagnetic compatibility. These standards help ensure that devices are safe for human use, although specific safety data for the PNS Device itself is not provided in the available research. ^{6 7 8 9 10}

How is the Freedom PNS System treatment different from other treatments for chronic pain?

The Freedom PNS System is unique because it is a design-specific peripheral nerve stimulation device, which means it is specifically created for targeting peripheral nerves to relieve chronic pain. Unlike older devices adapted from spinal cord stimulators, this system is minimally invasive and wireless, reducing complications and providing long-term pain relief without the widespread tingling sensation often associated with traditional methods. ^{3 5 11 12 13}

What is the purpose of this trial?

This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment. A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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) 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]

References

1. New Zealand 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. [2023]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

Technology for Peripheral Nerve Stimulation. [2015]

4. United States 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Real world experience with minimally invasive wireless percutaneous neuromodulation in a tertiary care centre. [2023]

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

Safe use of repetitive transcranial magnetic stimulation in patients with implanted vagus nerve stimulators. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Interpretation of the International Standard 2017 Version of Implantable Neurostimulators]. [2018]

8. United States 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. [2022]

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

Neuroprosthetics and the science of patient input. [2019]

10. England 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. [2019]

11. England pubmed.ncbi.nlm.nih.gov

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

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

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

13. Sweden pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation in intractable neuropathic pain. [2013]