Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction

Recruiting at 1 trial location

Overseen By Jonathan D Charlesworth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Noctrix Health, Inc.

Must be taking: Prescription opioids

Must not be taking: Antidepressants, Sleep medications

Disqualifiers: Epilepsy, Severe movement disorders, others

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

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a nerve-stimulating device can help patients with severe RLS reduce their opioid use without worsening their symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on a stable dose of prescription opioids for at least 3 months before joining the study.

What data supports the effectiveness of the treatment Noninvasive Peripheral Nerve Stimulation (NPNS)?

Research on peripheral nerve stimulation (PNS) for chronic pain suggests it can be effective, as seen in studies where patients experienced pain relief. Although specific data on NPNS is limited, similar treatments have shown positive outcomes in managing chronic pain. ^{1 2 3 4 5}

Is Noninvasive Peripheral Nerve Stimulation (NPNS) generally safe for humans?

Peripheral nerve stimulation (PNS), which is similar to NPNS, has been used for pain treatment since the 1960s. While there is a high rate of complications, these are usually minor and can often be fixed with simple outpatient procedures. Overall, PNS is considered safe, but improvements in equipment specifically designed for PNS could reduce complications. ^{6 7 8 9 10}

How is Noninvasive Peripheral Nerve Stimulation (NPNS) different from other treatments for neuropathic pain?

Noninvasive Peripheral Nerve Stimulation (NPNS) is unique because it uses a simple, external device to deliver low-frequency electrical stimulation directly to the skin, unlike other treatments that may require surgical implantation. This makes it a less invasive option for managing chronic pain. ^{11 12 13 14 15}

Research Team

Jonathan D Charlesworth, PhD

Principal Investigator

Noctrix Health, Inc.

Eligibility Criteria

Inclusion Criteria

You possess the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.

Subject is currently taking a stable dose of at least one prescription opioid for RLS, where the total opioid dose is less than or equal to 60mg morphine milligram equivalents (MME) per day.

Subject has signed a valid, Institutional Review Board (IRB)-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.

Exclusion Criteria

You have an ongoing condition like a severe infection, kidney disease, anemia or swelling in your lower legs.

You are allergic to the materials used for the electrodes or the clothing worn during the study.

You have Restless Leg Syndrome (RLS) that was caused by another medical condition that has already been diagnosed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Phase

Participants undergo a 1-2 week run-in phase to allow resolution of opioid withdrawal symptoms unrelated to RLS

1-2 weeks

Assessment Phase

A 1-week assessment phase to evaluate if RLS symptoms have increased after opioid dose reduction

1 week

Extension Phase (optional)

Participants who tolerate both step-downs have the option of an extension phase involving a third step-down with the same format

Up to 9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Noninvasive Peripheral Nerve Stimulation (NPNS)

Participant Groups

Group I: Noninvasive Peripheral Nerve Stimulation (NPNS) Experimental Treatment 1 Intervention

NPNS device programmed to deliver active stimulation.

Who Is Running the Clinical Trial?

Noctrix Health, Inc.

Lead Sponsor

Trials

7

Recruited

700+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

In a study of 100 patients with chronic intractable pain, peripheral nerve field stimulation (PNFS) led to an average pain reduction of 4.2 points on an 11-point scale, indicating significant efficacy in pain management.

The treatment was safe, with no long-term complications reported, and 72% of patients reduced their use of analgesics after PNFS, highlighting its potential to improve quality of life and change pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Verrills, P., Vivian, D., Mitchell, B., et al.[2011]

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]

Peripheral nerve stimulation (PNS) has been effectively used since the 1960s to treat various painful conditions, showcasing its long-standing efficacy as a neuromodulation technique.

The field of PNS is rapidly evolving, with ongoing advancements in technology and procedures that enhance its clinical applications and effectiveness in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of peripheral nerve stimulation. Slavin, KV.[2019]

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

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]

External noninvasive peripheral nerve stimulation (EN-PNS) showed significant short-term pain relief in patients with refractory neuropathic pain, with an average reduction of 2.8 points on a numerical rating scale after treatment.

In a study of 20 patients, 40% experienced improvements in quality of life and function, indicating that EN-PNS may be a beneficial option for managing chronic pain, although further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

In a study of patients with chronic neuropathic pain who had previously responded to external noninvasive peripheral nerve stimulation (EN-PNS), all five participants reported continued use of the device and ongoing pain relief after an average of 3.5 years.

Pain intensity significantly decreased from an average of 5.6 to 3.5, and the worst pain reported dropped from 8.6 to 4.8, indicating that EN-PNS can provide long-term benefits for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. Johnson, S., Goebel, A.[2022]

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]

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]

References

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

Is Response to a Pre-implant Diagnostic Peripheral Nerve Block Associated With Efficacy After Peripheral Nerve Stimulation Implantation? A Ten-Year Enterprise-Wide Analysis. [2023]

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

Peripheral Nerve Stimulation and Clinical Outcomes: A Retrospective Case Series. [2022]

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

Craniofacial Peripheral Nerve Stimulation: Analysis of a Single Institution Series. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. [2011]

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

Treatment of chronic axial back pain with 60-day percutaneous medial branch PNS: Primary end point results from a prospective, multicenter study. [2022]

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

Long-term peripheral nerve stimulation for painful nerve injuries. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

History of peripheral nerve stimulation. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Technical aspects of peripheral nerve stimulation: hardware and complications. [2019]

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

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. [2022]

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

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. [2022]

13. England 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. [2022]

14. 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]

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

Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain: An international cross-sectional survey of implanters. [2022]